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A Follow-on Study of the Long-Term Safety of Aripiprazole in Patients With Chronic Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435836
Recruitment Status : Terminated (Study terminated when aripiprazole available commercially per protocol)
First Posted : May 6, 2015
Results First Posted : September 21, 2015
Last Update Posted : September 21, 2015
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Aripiprazole
Enrollment 631
Recruitment Details This trial was conducted in 631 participants at 139 trial sites in 23 countries.
Pre-assignment Details All participants enrolled in this trial had previously participated in the double-blind aripiprazole; 89 participants from trial 31-97-301 and 542 participants from trial 31-98-304-01. NCT numbers were not available for these 2 trials as this was before the requirement. Studies were initiated in 1997 (31-97-201) and 1998 (31-98-304-01).
Arm/Group Title Aripiprazole
Hide Arm/Group Description All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Period Title: Overall Study
Started 631
Completed 0
Not Completed 631
Reason Not Completed
Lost to Follow-up             21
Lack of Efficacy             1
Withdrawal by Subject             236
Insufficient Clinical Response             26
Adverse Event             44
Sponsor discontinued trial             167
Noncompliance             27
Protocol Violation             6
Met Withdrawal Criteria             7
AE of Worsening Schizophrenia             96
Arm/Group Title Aripiprazole
Hide Arm/Group Description All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Baseline Participants 631
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 631 participants
37.5  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 631 participants
Female
264
  41.8%
Male
367
  58.2%
1.Primary Outcome
Title Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Participants Analyzed 631
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 619) -1.63  (7.92)
Week 2 (N= 595) -3.19  (9.64)
Week 4 (N= 586) -4.27  (10.90)
Week 6 (N= 573) -4.93  (12.07)
Week 8 (N= 552) -5.35  (13.03)
Week 12 (N= 532) -5.47  (14.61)
Week 16 (N= 517) -6.28  (14.44)
Week 24 (N= 489) -6.78  (14.22)
Week 36 (N= 458) -7.22  (14.17)
Week 48 (N= 426) -8.07  (15.72)
Week 60 (N= 395) -9.28  (14.71)
Week 72 (N= 382) -9.81  (15.98)
Week 84 (N= 362) -10.54  (15.92)
Week 96 (N= 340) -10.68  (16.40)
Week 108 (N= 328) -11.46  (16.56)
Week 120 (N= 316) -11.43  (17.01)
Week 132 (N= 306) -11.05  (17.37)
Week 144 (N= 288) -11.70  (17.72)
Week 156 (N= 279) -11.90  (17.47)
Week 168 (N= 272) -11.69  (17.11)
Week 180 (N= 268) -11.83  (17.41)
Week 192 (N= 255) -11.46  (18.00)
Week 204 (N= 239) -12.10  (17.72)
Week 216 (N= 238) -11.54  (17.05)
Week 228 (N= 224) -12.24  (17.53)
Week 240 (N= 183) -12.14  (19.35)
Week 252 (N= 139) -15.19  (18.61)
Week 264 (N= 83) -22.16  (21.07)
Week 276 (N= 58) -29.45  (20.33)
Week 288 (N= 56) -28.79  (20.66)
Week 300 (N= 55) -21.95  (19.91)
Week 312 (N= 37) -25.35  (18.41)
Week 324 (N= 38) -21.95  (17.45)
Week 336 (N= 28) -24.86  (17.78)
Week 348 (N= 8) -12.88  (14.71)
Week 360 (N= 10) -17.70  (35.32)
Week 372 (N= 3) -10.67  (4.16)
Week 384 (N= 5) -4.60  (9.07)
Week 396 (N= 10) -10.10  (12.67)
Week 408 (N= 9) -5.56  (7.06)
Week 420 (N= 4) -8.00  (2.83)
Week 432 (N= 3) -13.67  (24.19)
Week 444 (N= 1) -28.00 [1]   (NA)
Week 456 (N= 4) -48.25  (32.12)
Week 468 (N= 2) -36.00  (2.83)
Week 480 (N= 1) -10.00 [2]   (NA)
Week 492 (N= 9) -10.00  (13.52)
Week 504 (N= 2) -9.50  (28.99)
Week 636 (N= 5) -7.60  (22.35)
Week 648 (N= 2) -10.00  (14.14)
Week 660 (N= 3) -15.33  (19.66)
Week 672 (N= 1) 1.00 [2]   (NA)
Week 696 (N= 1) -7.00 [2]   (NA)
Last Visit (N= 629) -2.30  (22.21)
[1]
Standard deviation (SD) was not calculated as N= 1.
[2]
SD was not calculated as N= 1.
2.Primary Outcome
Title Mean Change From Baseline in PANSS Positive Sub-scale Score by Week
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
Time Frame Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Participants Analyzed 631
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 619) -0.39  (2.51)
Week 2 (N= 595) -0.81  (3.15)
Week 4 (N= 586) -1.13  (3.47)
Week 6 (N= 573) -1.23  (3.70)
Week 8 (N= 552) -1.30  (3.97)
Week 12 (N= 533) -1.24  (4.43)
Week 16 (N= 517) -1.43  (4.20)
Week 24 (N= 489) -1.54  (4.26)
Week 36 (N= 458) -1.56  (4.20)
Week 48 (N= 426) -1.73  (4.64)
Week 60 (N= 395) -2.01  (4.32)
Week 72 (N= 382) -2.08  (4.63)
Week 84 (N= 362) -2.26  (4.65)
Week 96 (N= 340) -2.26  (4.81)
Week 108 (N= 328) -2.50  (4.76)
Week 120 (N= 316) -2.45  (4.84)
Week 132 (N= 306) -2.25  (5.02)
Week 144 (N= 289) -2.49  (5.03)
Week 156 (N= 279) -2.46  (4.87)
Week 168 (N= 272) -2.35  (4.62)
Week 180 (N= 268) -2.40  (4.78)
Week 192 (N= 255) -2.22  (4.91)
Week 204 (N= 239) -2.48  (4.86)
Week 216 (N= 238) -2.21  (4.57)
Week 228 (N= 224) -2.42  (4.51)
Week 240 (N= 183) -2.10  (5.16)
Week 252 (N= 139) -2.74  (4.81)
Week 264 (N= 83) -4.24  (5.69)
Week 276 (N= 58) -5.90  (5.80)
Week 288 (N= 56) -6.30  (5.61)
Week 300 (N= 55) -4.16  (5.54)
Week 312 (N= 37) -5.27  (5.57)
Week 324 (N= 38) -4.45  (5.64)
Week 336 (N= 28) -5.46  (5.73)
Week 348 (N= 8) -0.75  (1.04)
Week 360 (N= 10) -3.80  (7.60)
Week 372 (N= 3) -0.67  (0.58)
Week 384 (N= 5) -0.80  (3.96)
Week 396 (N= 10) -2.40  (3.63)
Week 408 (N= 9) -0.89  (2.80)
Week 420 (N= 4) -0.75  (1.50)
Week 432 (N= 3) -4.67  (8.08)
Week 444 (N= 1) -9.00 [1]   (NA)
Week 456 (N= 4) -10.50  (5.97)
Week 468 (N= 2) -6.50  (3.54)
Week 480 (N= 1) -2.00 [1]   (NA)
Week 492 (N= 9) -2.00  (2.65)
Week 504 (N= 2) -2.50  (7.78)
Week 636 (N= 5) -1.80  (4.02)
Week 648 (N= 2) -4.50  (7.78)
Week 660 (N= 3) -2.00  (2.65)
Week 672 (N= 1) 1.00 [1]   (NA)
Week 696 (N= 1) -1.00 [1]   (NA)
Last Visit (N= 629) 0.23  (6.58)
[1]
SD was not calculated as N= 1.
3.Primary Outcome
Title Mean Change From Baseline in PANSS Negative Sub-scale Score by Week
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
Time Frame Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Participants Analyzed 631
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 619) -0.35  (2.18)
Week 2 (N= 595) -0.82  (2.59)
Week 4 (N= 586) -1.05  (3.04)
Week 6 (N= 573) -1.24  (3.38)
Week 8 (N= 552) -1.41  (3.54)
Week 12 (N= 532) -1.54  (4.01)
Week 16 (N= 517) -1.85  (4.12)
Week 24 (N= 489) -2.02  (4.13)
Week 36 (N= 458) -2.16  (4.41)
Week 48 (N= 426) -2.43  (4.71)
Week 60 (N= 395) -2.75  (4.38)
Week 72 (N= 382) -2.94  (4.79)
Week 84 (N= 362) -3.17  (4.87)
Week 96 (N= 340) -3.22  (4.99)
Week 108 (N= 328) -3.36  (4.99)
Week 120 (N= 316) -3.37  (5.25)
Week 132 (N= 306) -3.41  (5.29)
Week 144 (N= 288) -3.58  (5.43)
Week 156 (N= 279) -3.70  (5.27)
Week 168 (N= 272) -3.68  (5.28)
Week 180 (N= 268) -3.69  (5.21)
Week 192 (N= 255) -3.65  (5.40)
Week 204 (N= 239) -3.79  (5.37)
Week 216 (N= 238) -3.74  (5.17)
Week 228 (N= 224) -3.90  (5.38)
Week 240 (N= 183) -4.09  (5.86)
Week 252 (N= 139) -4.88  (5.69)
Week 264 (N= 83) -6.87  (6.50)
Week 276 (N= 58) -8.71  (6.57)
Week 288 (N= 56) -8.32  (6.85)
Week 300 (N= 55) -6.58  (6.42)
Week 312 (N= 37) -7.51  (5.43)
Week 324 (N= 38) -6.63  (4.44)
Week 336 (N= 28) -7.43  (4.59)
Week 348 (N= 8) -4.88  (5.89)
Week 360 (N= 10) -5.60  (9.40)
Week 372 (N= 3) -4.33  (1.53)
Week 384 (N= 5) 0.00  (2.12)
Week 396 (N= 10) -2.90  (3.67)
Week 408 (N= 9) -1.22  (2.54)
Week 420 (N= 4) -2.25  (2.22)
Week 432 (N= 3) -2.67  (7.51)
Week 444 (N= 1) -6.00 [1]   (NA)
Week 456 (N= 4) -13.75  (9.95)
Week 468 (N= 2) -9.00  (5.66)
Week 480 (N= 1) -5.00 [1]   (NA)
Week 492 (N= 9) -2.00  (3.61)
Week 504 (N= 2) -1.50  (12.02)
Week 636 (N= 5) -1.80  (5.85)
Week 648 (N= 2) 0.00  (0.00)
Week 660 (N= 3) -4.67  (6.66)
Week 672 (N= 1) 1.00 [1]   (NA)
Week 696 (N= 1) -3.00 [1]   (NA)
Last Visit (N= 629) -1.34  (6.09)
[1]
SD was not calculated as N= 1.
4.Primary Outcome
Title Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week
Hide Description The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Time Frame Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Participants Analyzed 631
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 619) -0.07  (0.49)
Week 2 (N= 595) -0.13  (0.60)
Week 4 (N= 586) -0.20  (0.67)
Week 6 (N= 573) -0.23  (0.78)
Week 8 (N= 552) -0.25  (0.79)
Week 12 (N= 533) -0.25  (0.86)
Week 16 (N= 517) -0.30  (0.86)
Week 24 (N= 489) -0.31  (0.89)
Week 36 (N= 458) -0.32  (0.95)
Week 48 (N= 426) -0.38  (0.94)
Week 60 (N= 395) -0.45  (0.92)
Week 72 (N= 382) -0.45  (0.93)
Week 84 (N= 362) -0.49  (0.95)
Week 96 (N= 340) -0.48  (0.99)
Week 108 (N= 328) -0.51  (0.95)
Week 120 (N= 316) -0.53  (0.98)
Week 132 (N= 306) -0.48  (1.03)
Week 144 (N= 290) -0.52  (1.04)
Week 156 (N= 279) -0.53  (1.00)
Week 168 (N= 272) -0.53  (0.96)
Week 180 (N= 268) -0.55  (0.98)
Week 192 (N= 255) -0.54  (1.04)
Week 204 (N= 239) -0.55  (1.01)
Week 216 (N= 238) -0.53  (0.99)
Week 228 (N= 232) -0.56  (1.00)
Week 240 (N= 216) -0.56  (1.06)
Week 252 (N= 208) -0.58  (0.96)
Week 264 (N= 194) -0.58  (1.04)
Week 276 (N= 187) -0.61  (1.01)
Week 288 (N= 177) -0.64  (1.02)
Week 300 (N= 167) -0.63  (0.99)
Week 312 (N= 145) -0.57  (1.01)
Week 324 (N= 137) -0.60  (0.99)
Week 336 (N= 121) -0.59  (0.95)
Week 348 (N= 114) -0.48  (0.97)
Week 360 (N= 105) -0.54  (0.98)
Week 372 (N= 93) -0.49  (0.94)
Week 384 (N= 91) -0.51  (0.94)
Week 396 (N= 80) -0.53  (1.06)
Week 408 (N= 69) -0.62  (0.96)
Week 420 (N= 61) -0.70  (1.07)
Week 432 (N= 58) -0.69  (1.16)
Week 444 (N= 51) -0.59  (0.96)
Week 456 (N= 48) -0.65  (1.10)
Week 468 (N= 37) -0.46  (1.04)
Week 480 (N= 33) -0.42  (0.83)
Week 492 (N= 31) -0.55  (0.99)
Week 504 (N= 21) -0.57  (0.93)
Week 516 (N= 19) -0.53  (0.84)
Week 528 (N= 19) -0.47  (0.90)
Week 540 (N= 18) -0.61  (0.70)
Week 552 (N= 18) -0.56  (0.86)
Week 564 (N= 17) -0.41  (0.87)
Week 576 (N= 17) -0.35  (0.86)
Week 588 (N= 17) -0.41  (0.87)
Week 600 (N= 16) -0.44  (0.89)
Week 612 (N= 16) -0.44  (0.89)
Week 624 (N= 16) -0.50  (0.73)
Week 636 (N= 16) -0.44  (0.89)
Week 648 (N= 10) -0.70  (0.67)
Week 660 (N= 8) -0.50  (0.53)
Week 672 (N= 3) -0.67  (0.58)
Week 684 (N= 1) -1.00 [1]   (NA)
Week 696 (N= 1) -1.00 [1]   (NA)
Last Visit (N= 629) -0.00  (1.31)
[1]
SD was not calculated as N= 1.
5.Primary Outcome
Title Mean Clinical Global Impression of Improvement (CGI-I) by Week
Hide Description

The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5

=minimally worse; 6 = much worse; and 7 = very much worse.

Time Frame Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Participants Analyzed 631
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 619) 3.60  (0.93)
Week 2 (N= 595) 3.42  (0.98)
Week 4 (N= 586) 3.29  (1.02)
Week 6 (N= 573) 3.21  (1.08)
Week 8 (N= 552) 3.17  (1.10)
Week 12 (N= 533) 3.16  (1.12)
Week 16 (N= 517) 3.08  (1.18)
Week 24 (N= 489) 3.03  (1.14)
Week 36 (N= 458) 2.95  (1.14)
Week 48 (N= 426) 2.88  (1.17)
Week 60 (N= 395) 2.76  (1.14)
Week 72 (N= 382) 2.73  (1.11)
Week 84 (N= 362) 2.67  (1.11)
Week 96 (N= 340) 2.67  (1.15)
Week 108 (N= 328) 2.60  (1.12)
Week 120 (N= 316) 2.58  (1.15)
Week 132 (N= 306) 2.62  (1.17)
Week 144 (N= 290) 2.59  (1.20)
Week 156 (N= 279) 2.58  (1.16)
Week 168 (N= 272) 2.57  (1.15)
Week 180 (N= 268) 2.57  (1.16)
Week 192 (N= 255) 2.59  (1.20)
Week 204 (N= 239) 2.56  (1.16)
Week 216 (N= 238) 2.56  (1.20)
Week 228 (N= 232) 2.49  (1.17)
Week 240 (N= 216) 2.48  (1.21)
Week 252 (N= 208) 2.37  (1.13)
Week 264 (N= 194) 2.14  (1.07)
Week 276 (N= 187) 2.16  (1.03)
Week 288 (N= 177) 2.26  (1.06)
Week 300 (N= 167) 2.26  (1.16)
Week 312 (N= 145) 2.18  (1.11)
Week 324 (N= 137) 2.23  (1.05)
Week 336 (N= 121) 2.03  (1.09)
Week 348 (N= 114) 2.45  (1.00)
Week 360 (N= 105) 2.53  (1.36)
Week 372 (N= 93) 2.14  (1.07)
Week 384 (N= 91) 2.50  (1.52)
Week 396 (N= 80) 3.00  (1.63)
Week 408 (N= 69) 2.50  (1.18)
Week 420 (N= 61) 2.43  (1.40)
Week 432 (N= 58) 2.00  (1.73)
Week 444 (N= 51) 1.00 [1]   (NA)
Week 456 (N= 48) 1.83  (0.75)
Week 468 (N= 37) 2.00  (0.00)
Week 480 (N= 33) 2.00 [1]   (NA)
Week 492 (N= 9) 2.33  (1.32)
Week 504 (N= 2) 2.50  (2.12)
Week 528 (N= 1) 4.00 [1]   (NA)
Week 636 (N= 5) 2.00  (0.00)
Week 648 (N= 2) 1.50  (0.71)
Week 660 (N= 3) 2.33  (1.15)
Week 672 (N= 3) 1.00 [1]   (NA)
Week 696 (N= 1) 1.00 [1]   (NA)
Last Visit (N= 629) 3.35  (1.60)
[1]
SD was not calculated as N= 1.
6.Primary Outcome
Title Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score
Hide Description The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. The questionnaire includes questions on the following symptoms. 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The usual cut-off points are: 0 to 6 = normal/ symptom absent, 7 to 19 = mild depression, 20 to 34 = moderate depression, >34 = severe depression.
Time Frame Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Participants Analyzed 631
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 619) -0.78  (3.62)
Week 2 (N= 595) -1.13  (4.09)
Week 4 (N= 586) -1.38  (4.73)
Week 6 (N= 572) -1.54  (5.15)
Week 8 (N= 552) -1.40  (4.98)
Week 12 (N= 533) -1.31  (5.77)
Week 16 (N= 517) -1.60  (5.41)
Week 24 (N= 489) -1.61  (5.75)
Week 36 (N= 458) -1.66  (5.75)
Week 48 (N= 425) -1.75  (5.47)
Week 60 (N= 395) -2.13  (5.41)
Week 72 (N= 382) -2.21  (5.29)
Week 84 (N= 362) -2.33  (5.51)
Week 96 (N= 339) -2.26  (5.70)
Week 108 (N= 328) -2.30  (5.68)
Week 120 (N= 316) -2.40  (5.67)
Week 132 (N= 306) -2.22  (5.85)
Week 144 (N= 291) -2.47  (5.85)
Week 156 (N= 279) -2.51  (5.64)
Week 168 (N= 272) -2.51  (5.49)
Week 180 (N= 268) -2.73  (5.67)
Week 192 (N= 255) -2.53  (6.05)
Week 204 (N= 239) -2.69  (6.20)
Week 216 (N= 238) -2.50  (5.87)
Week 228 (N= 224) -2.62  (5.82)
Week 240 (N= 183) -2.92  (6.50)
Week 252 (N= 139) -3.63  (6.53)
Week 264 (N= 83) -5.52  (7.89)
Week 276 (N= 58) -7.71  (8.88)
Week 288 (N= 56) -7.57  (8.64)
Week 300 (N= 55) -6.15  (7.52)
Week 312 (N= 37) -7.24  (8.51)
Week 324 (N= 38) -6.32  (8.76)
Week 336 (N= 28) -7.21  (8.01)
Week 348 (N= 8) -4.00  (7.45)
Week 360 (N= 10) -2.80  (16.09)
Week 372 (N= 3) -2.67  (2.08)
Week 384 (N= 5) 0.00  (0.00)
Week 396 (N= 10) -1.40  (2.95)
Week 408 (N= 9) -1.89  (1.27)
Week 420 (N= 4) 0.75  (4.11)
Week 432 (N= 3) -2.33  (5.86)
Week 444 (N= 1) -1.00 [1]   (NA)
Week 456 (N= 5) -9.60  (8.85)
Week 468 (N= 2) -3.00  (2.83)
Week 480 (N= 1) 0.00 [1]   (NA)
Week 492 (N= 9) -6.56  (8.44)
Week 504 (N= 2) -13.50  (13.44)
Week 636 (N= 5) 0.40  (3.36)
Week 648 (N= 2) -1.00  (1.41)
Week 660 (N= 3) -4.33  (2.31)
Week 672 (N= 1) -2.00 [1]   (NA)
Week 696 (N= 1) -1.00 [1]   (NA)
Last Visit (N= 629) -0.31  (8.02)
[1]
SD was not calculated as N= 1.
7.Primary Outcome
Title Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week
Hide Description The SAS is composed of 10 items. This scale contains 10 items: Gait, Arm dropping, Shoulder shaking, Elbow rigidity, Wrist rigidity, Head rotation, Glabella Tap, Tremor, Salivation, Akathisia. Grade of severity of each item is rated using a 5-point scale, 1 (normal) and 5 (most severe). The total score ranges from 10 to 50. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.
Time Frame Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Participants Analyzed 631
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 618) -0.78  (3.05)
Week 2 (N= 594) -1.01  (3.32)
Week 4 (N= 585) -1.06  (3.68)
Week 6 (N= 572) -1.14  (3.94)
Week 8 (N= 550) -1.19  (4.00)
Week 12 (N= 532) -1.28  (4.03)
Week 16 (N= 516) -1.27  (4.18)
Week 24 (N= 488) -1.24  (3.91)
Week 36 (N= 456) -1.10  (3.79)
Week 48 (N= 426) -1.33  (4.14)
Week 60 (N= 395) -1.25  (3.89)
Week 72 (N= 382) -1.36  (4.07)
Week 84 (N= 362) -1.33  (4.16)
Week 96 (N= 338) -1.24  (3.92)
Week 108 (N= 328) -1.29  (3.83)
Week 120 (N= 316) -1.22  (3.83)
Week 132 (N= 306) -1.26  (3.88)
Week 144 (N= 289) -1.26  (3.99)
Week 156 (N= 278) -1.33  (4.04)
Week 168 (N= 272) -1.31  (3.92)
Week 180 (N= 268) -1.43  (4.08)
Week 192 (N= 255) -1.46  (4.07)
Week 204 (N= 239) -1.49  (4.16)
Week 216 (N= 238) -1.39  (3.48)
Week 228 (N= 224) -1.44  (3.55)
Week 240 (N= 183) -1.68  (3.72)
Week 252 (N= 139) -2.11  (4.16)
Week 264 (N= 83) -2.89  (4.99)
Week 276 (N= 58) -3.84  (5.64)
Week 288 (N= 56) -3.88  (5.77)
Week 300 (N= 55) -2.53  (4.55)
Week 312 (N= 37) -2.30  (4.07)
Week 324 (N= 38) -1.76  (4.10)
Week 336 (N= 28) -1.64  (3.90)
Week 348 (N= 8) -2.00  (2.78)
Week 360 (N= 9) -0.44  (5.75)
Week 372 (N= 3) -1.00  (0.00)
Week 384 (N= 5) -0.20  (0.45)
Week 396 (N= 10) -0.30  (1.16)
Week 408 (N= 9) -0.89  (1.27)
Week 420 (N= 4) -1.25  (1.50)
Week 432 (N= 3) -1.00  (1.73)
Week 444 (N= 1) 1.00 [1]   (NA)
Week 456 (N= 5) -7.20  (8.87)
Week 468 (N= 2) 0.00  (0.00)
Week 480 (N= 1) -1.00 [1]   (NA)
Week 492 (N= 9) -3.22  (5.33)
Week 504 (N= 2) -3.00  (4.24)
Week 636 (N= 5) -0.20  (0.45)
Week 648 (N= 2) 0.00  (0.00)
Week 660 (N= 3) -1.00  (1.00)
Week 672 (N= 1) -3.00 [1]   (NA)
Week 696 (N= 1) -7.00 [1]   (NA)
Last Visit (N= 628) -1.36  (4.31)
[1]
SD was not calculated as N= 1.
8.Primary Outcome
Title Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week
Hide Description BARS consisted of 4 items: objective observation of akathisia by study physician, subjective feelings of restlessness by participant, participant distress due to akathisia, global evaluation of akathisia. The first 3 items were rated on a 4-point scale: 0 = absence of symptoms to 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). Participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were elicited by direct questioning. The BARS Global Score was derived from the global clinical assessment of akathisia from the BARS panel. Total score ranges from 0 to 14. Negative changes from baseline indicate improvement, with higher negative values indicating better improvement.
Time Frame Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Participants Analyzed 631
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 618) -0.15  (0.67)
Week 2 (N= 595) -0.20  (0.70)
Week 4 (N= 586) -0.20  (0.74)
Week 6 (N= 572) -0.23  (0.76)
Week 8 (N= 552) -0.22  (0.79)
Week 12 (N= 533) -0.22  (0.78)
Week 16 (N= 517) -0.22  (0.77)
Week 24 (N= 489) -0.22  (0.74)
Week 36 (N= 458) -0.21  (0.75)
Week 48 (N= 425) -0.20  (0.75)
Week 60 (N= 395) -0.20  (0.70)
Week 72 (N= 382) -0.19  (0.73)
Week 84 (N= 362) -0.21  (0.74)
Week 96 (N= 340) -0.21  (0.79)
Week 108 (N= 327) -0.21  (0.77)
Week 120 (N= 316) -0.20  (0.75)
Week 132 (N= 306) -0.22  (0.76)
Week 144 (N= 291) -0.22  (0.79)
Week 156 (N= 278) -0.24  (0.79)
Week 168 (N= 272) -0.22  (0.78)
Week 180 (N= 268) -0.24  (0.81)
Week 192 (N= 255) -0.29  (0.79)
Week 204 (N= 238) -0.29  (0.80)
Week 216 (N= 237) -0.26  (0.76)
Week 228 (N= 223) -0.26  (0.78)
Week 240 (N= 183) -0.24  (0.75)
Week 252 (N= 139) -0.29  (0.81)
Week 264 (N= 83) -0.51  (1.06)
Week 276 (N= 58) -0.69  (1.16)
Week 288 (N= 56) -0.64  (1.09)
Week 300 (N= 55) -0.51  (0.96)
Week 312 (N= 37) -0.35  (0.68)
Week 324 (N= 38) -0.26  (0.60)
Week 336 (N= 28) -0.29  (0.66)
Week 348 (N= 8) -0.75  (1.04)
Week 360 (N= 9) -0.22  (0.67)
Week 372 (N= 3) 0.00  (0.00)
Week 384 (N= 5) 0.00  (0.00)
Week 396 (N= 10) -0.10  (0.32)
Week 408 (N= 9) -0.33  (0.71)
Week 420 (N= 4) -0.25  (0.50)
Week 432 (N= 3) 0.00  (0.00)
Week 444 (N= 1) 0.00 [1]   (NA)
Week 456 (N= 5) -1.40  (1.67)
Week 468 (N= 2) 0.00  (0.00)
Week 480 (N= 1) 0.00 [1]   (NA)
Week 492 (N= 9) -0.56  (1.01)
Week 504 (N= 2) -1.50  (0.71)
Week 636 (N= 5) -0.40  (0.89)
Week 648 (N= 2) 0.00  (0.00)
Week 660 (N= 3) -0.67  (1.15)
Week 672 (N= 1) -4.00 [1]   (NA)
Week 696 (N= 1) 0.00 [1]   (NA)
Last Visit (N= 629) -0.26  (0.85)
[1]
SD was not calculated as N= 1.
9.Primary Outcome
Title Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week
Hide Description The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). For this scale, the participant was seated on a hard, firm chair. These items are rated on a five-point scale: 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). The total score ranges from 0 to 40. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.
Time Frame Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Participants Analyzed 631
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 619) -0.21  (1.61)
Week 2 (N= 595) -0.29  (1.77)
Week 4 (N= 586) -0.28  (1.96)
Week 6 (N= 572) -0.34  (2.25)
Week 8 (N= 552) -0.34  (2.22)
Week 12 (N= 533) -0.37  (2.26)
Week 16 (N= 517) -0.39  (2.31)
Week 24 (N= 489) -0.35  (2.08)
Week 36 (N= 458) -0.21  (1.85)
Week 48 (N= 425) -0.35  (2.17)
Week 60 (N= 395) -0.33  (2.02)
Week 72 (N= 382) -0.31  (2.10)
Week 84 (N= 362) -0.31  (2.12)
Week 96 (N= 340) -0.25  (1.84)
Week 108 (N= 328) -0.27  (1.88)
Week 120 (N= 316) -0.26  (1.85)
Week 132 (N= 306) -0.26  (1.91)
Week 144 (N= 290) -0.29  (1.97)
Week 156 (N= 279) -0.31  (2.04)
Week 168 (N= 272) -0.29  (1.87)
Week 180 (N= 268) -0.34  (2.08)
Week 192 (N= 255) -0.35  (2.08)
Week 204 (N= 239) -0.30  (2.06)
Week 216 (N= 238) -0.26  (1.50)
Week 228 (N= 224) -0.31  (1.41)
Week 240 (N= 183) -0.31  (1.44)
Week 252 (N= 139) -0.40  (1.59)
Week 264 (N= 83) -0.61  (1.95)
Week 276 (N= 58) -0.76  (2.30)
Week 288 (N= 56) -0.57  (2.72)
Week 300 (N= 55) -0.18  (1.45)
Week 312 (N= 37) -0.35  (0.68)
Week 324 (N= 38) -0.32  (0.57)
Week 336 (N= 28) -0.36  (0.56)
Week 348 (N= 8) -0.50  (1.07)
Week 360 (N= 9) -0.44  (0.73)
Week 372 (N= 3) 0.00  (0.00)
Week 384 (N= 5) 0.00  (0.00)
Week 396 (N= 10) 0.00  (0.00)
Week 408 (N= 9) 0.00  (0.00)
Week 420 (N= 4) 0.00  (0.00)
Week 432 (N= 3) 0.00  (0.00)
Week 444 (N= 1) 0.00 [1]   (NA)
Week 456 (N= 5) -1.00  (2.24)
Week 468 (N= 2) 0.00  (0.00)
Week 480 (N= 1) 0.00 [1]   (NA)
Week 492 (N= 9) -0.44  (0.53)
Week 504 (N= 2) -0.50  (0.71)
Week 636 (N= 5) 0.20  (0.45)
Week 648 (N= 2) 0.00  (0.00)
Week 660 (N= 3) 0.00  (0.00)
Week 672 (N= 1) 0.00 [1]   (NA)
Week 696 (N= 1) 0.00 [1]   (NA)
Last Visit (N= 629) -0.39  (2.36)
[1]
SD was not calculated as N= 1.
10.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial.
Time Frame Baseline to Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample includes all randomized participants who receive at least one dose of study medication.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Participants Analyzed 631
Measure Type: Number
Unit of Measure: Participants
Participants with serious TEAEs 179
Participants with severe TEAEs 116
Participants discontinued medication due to AE 140
Participants with TEAEs 523
Participants discontinued due to AEs or death 140
11.Primary Outcome
Title Percentage of Participants With Vital Signs of Potential Clinical Relevance
Hide Description The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria.
Time Frame Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample includes all randomized participants who receive at least one dose of study medication.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Participants Analyzed 631
Measure Type: Number
Unit of Measure: percentage of participants
Heart rate sitting increase ≥15 bpm (N=625) 0.5
Systolic sitting BP increase ≥20 mmHg (N=627) 0.8
Systolic sitting BP decrease ≥20 mmHg (N=627) 1.3
Diastolic sitting BP increase ≥15mmHg (N=627) 3.0
Weight gain ≥7% (N=622) 38.9
Weight loss ≥7% (N=622) 23.6
12.Primary Outcome
Title Percentage of Participants With ECG Measurements of Potential Clinical Relevance
Hide Description The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria.
Time Frame Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample includes all randomized participants who receive at least one dose of study medication.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Participants Analyzed 631
Measure Type: Number
Unit of Measure: Percentage of participants
Tachycardia (N=612) 0.8
Bradycardia (N=612) 7.5
Sinus tachycardia (N=612) 0.8
Sinus bradycardia (N=612) 7.4
Ventricular premature beat (N=612) 2.9
Primary atrioventricular block (N=606) 2.5
Secondary atrioventricular block (N=612) 0.2
Left bundle branch block (N=612) 0.2
Right bundle branch block (N=612) 16.0
Pre-excitation syndrome (N=612) 0.3
Other intraventricular conduction block (N=611) 1.8
Acute infarction (N=612) 0.2
Old infarction (N=612) 0.7
QTcB (N=612) 8.0
QTcF (N=611) 2.1
QTcN (N=611) 2.3
13.Primary Outcome
Title Percentage of Participants With Laboratory Values of Potential Clinical Relevance
Hide Description The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.
Time Frame Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Sample includes all randomized participants who receive at least one dose of study medication.
Arm/Group Title Aripiprazole
Hide Arm/Group Description:
All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
Overall Number of Participants Analyzed 631
Measure Type: Number
Unit of Measure: Percentage of participants
Alanine aminotransferase (IU/L) (N=626) 1.1
Aspartate aminotransferase (IU/L) (N=626) 1.0
Bilirubin (mg/dl) (high)(N=626) 3.0
Calcium (mg/dl) (low) (N=626) 3.4
Chloride (meq/l) (low) (N=626) 0.5
Chloride (meq/l) (high) (N=626) 0.2
Creatinine phosphokinase (IU/L) (N=626) 14.9
Creatinine (mg/dl) (N=617) 0.5
Glucose (mg/dl) (N=626) 3.0
Lactic dehydrogenase (IU/L) (N=626) 0.2
Potassium (meq/l) (low) (N=626) 0.2
Potassium (meq/l) (high) (N=626) 5.3
Sodium (meq/l) (low) (N=626) 0.5
Sodium (meq/l) (high) (N=626) 0.2
Urea nitrogen (mg/dl) (N=626) 0.8
Uric acid (mg/dl) (N=626) 1.0
Eosinophils (%) (N=624) 3.2
Hematocrit (%) (N=623) 2.7
Hemoglobin (g/dl) (N=625) 2.4
Platelet count (per cubic mm) (low) (N=625) 0.2
Platelet count (per cubic mm) (high) (N=625) 0.3
White blood count (thou/mcl) (low) (N=625) 1.1
White blood count (thou/mcl) (high) (N=625) 3.8
Glucose, urine (N=613) 1.6
Protein, urine (N=599) 1.8
Time Frame From the signing of the informed consent to 30 days after the end of study treatment. The investigator continued to report any significant follow-up information on the AE up to the time the event had been resolved.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aripiprazole
Hide Arm/Group Description All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
All-Cause Mortality
Aripiprazole
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole
Affected / at Risk (%)
Total   179/631 (28.37%) 
Blood and lymphatic system disorders   
Anemia * 1  1/631 (0.16%) 
Cardiac disorders   
Atrial flutter * 1  1/631 (0.16%) 
Cardiac failure * 1  2/631 (0.32%) 
Myocardial infarction * 1  1/631 (0.16%) 
Myocardial ischaemia * 1  1/631 (0.16%) 
Palpitations * 1  1/631 (0.16%) 
Eye disorders   
Cataract * 1  1/631 (0.16%) 
Glaucoma * 1  1/631 (0.16%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/631 (0.16%) 
Duodenal ulcer perforation * 1  1/631 (0.16%) 
Gastric ulcer haemorrhage * 1  1/631 (0.16%) 
Inguinal hernia * 1  1/631 (0.16%) 
Umbilical hernia * 1  1/631 (0.16%) 
Infections and infestations   
Appendicitis * 1  1/631 (0.16%) 
Gangrene * 1  1/631 (0.16%) 
Pneumonia * 1  1/631 (0.16%) 
Syphilis * 1  1/631 (0.16%) 
Injury, poisoning and procedural complications   
Foreign body * 1  1/631 (0.16%) 
Overdose * 1  3/631 (0.48%) 
Toxicity to various agents * 1  2/631 (0.32%) 
Traumatic liver injury * 1  1/631 (0.16%) 
Investigations   
Blood creatinine phosphokinase increased * 1  1/631 (0.16%) 
Electrocardiogram QT prolonged * 1  1/631 (0.16%) 
Weight decreased * 1  2/631 (0.32%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  1/631 (0.16%) 
Diabetes mellitus * 1  2/631 (0.32%) 
Type 2 diabetes mellitus * 1  1/631 (0.16%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/631 (0.16%) 
Myopathy * 1  1/631 (0.16%) 
Metastases to liver * 1  1/631 (0.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bronchial carcinoma * 1  1/631 (0.16%) 
Colon cancer * 1  1/631 (0.16%) 
Malignant melanoma * 1  1/631 (0.16%) 
Metastatic malignant melanoma * 1  1/631 (0.16%) 
Nervous system disorders   
Akathisia * 1  2/631 (0.32%) 
Carpal tunnel syndrome * 1  1/631 (0.16%) 
Dizziness * 1  1/631 (0.16%) 
Multiple sclerosis * 1  1/631 (0.16%) 
Psychiatric disorders   
Abnormal behaviour * 1  2/631 (0.32%) 
Adjustment disorder * 1  1/631 (0.16%) 
Agression * 1  4/631 (0.63%) 
Agitation * 1  2/631 (0.32%) 
Alcohol abuse * 1  1/631 (0.16%) 
Anxiety * 1  10/631 (1.58%) 
Completed suicide * 1  4/631 (0.63%) 
Confusional state * 1  1/631 (0.16%) 
Delusion * 1  2/631 (0.32%) 
Depressed mood * 1  1/631 (0.16%) 
Depression * 1  2/631 (0.32%) 
Depressive symptom * 1  1/631 (0.16%) 
Drug abuse * 1  1/631 (0.16%) 
Hallucination * 1  4/631 (0.63%) 
Hypomania * 1  1/631 (0.16%) 
Illusion * 1  1/631 (0.16%) 
Insomnia * 1  1/631 (0.16%) 
Intentional self-injury * 1  1/631 (0.16%) 
Persecutory delusion * 1  1/631 (0.16%) 
Psychotic disorder * 1  20/631 (3.17%) 
Restlessness * 1  1/631 (0.16%) 
Schizophrenia * 1  85/631 (13.47%) 
Schizophrenia, paranoid type * 1  1/631 (0.16%) 
Suicidal ideation * 1  2/631 (0.32%) 
Suicidal attempt * 1  6/631 (0.95%) 
Reproductive system and breast disorders   
Bartholin's cyst * 1  1/631 (0.16%) 
Menorrhagia * 1  1/631 (0.16%) 
Ovarian cyst * 1  1/631 (0.16%) 
Prostatic disorder * 1  1/631 (0.16%) 
Uterine haemorrhage * 1  1/631 (0.16%) 
Respiratory, thoracic and mediastinal disorders   
Bronchitis chronic * 1  1/631 (0.16%) 
Chronic obstructive pulmonary disease * 1  1/631 (0.16%) 
Pulmonary thrombosis * 1  1/631 (0.16%) 
Respiratory failure * 1  1/631 (0.16%) 
Social circumstances   
Homicide * 1  1/631 (0.16%) 
Respite care * 1  2/631 (0.32%) 
Social stay hospitalisation * 1  16/631 (2.54%) 
Substance use * 1  1/631 (0.16%) 
Vascular disorders   
Hypertension * 1  1/631 (0.16%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole
Affected / at Risk (%)
Total   364/631 (57.69%) 
Infections and infestations   
Influenza * 1  47/631 (7.45%) 
Investigations   
Weight increased * 1  56/631 (8.87%) 
Nervous system disorders   
Akathisia * 1  84/631 (13.31%) 
Extrapyramidal disorder * 1  50/631 (7.92%) 
Headache * 1  48/631 (7.61%) 
Tremor * 1  50/631 (7.92%) 
Psychiatric disorders   
Anxiety * 1  73/631 (11.57%) 
Insomnia * 1  118/631 (18.70%) 
Schizophrenia * 1  79/631 (12.52%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
The study was terminated prematurely by the sponsor. The protocol specified that the study would run until Abilify (aripiprazole) was commercially available in all site countries.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02435836     History of Changes
Other Study ID Numbers: 31-97-303
First Submitted: April 15, 2015
First Posted: May 6, 2015
Results First Submitted: July 1, 2015
Results First Posted: September 21, 2015
Last Update Posted: September 21, 2015