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Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia (ASPIRE)

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ClinicalTrials.gov Identifier: NCT00731549
Recruitment Status : Completed
First Posted : August 11, 2008
Results First Posted : November 11, 2014
Last Update Posted : November 26, 2014
Sponsor:
Collaborator:
Covance
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 IM Depot
Enrollment 1081
Recruitment Details This open label Phase 3 study enrolled participants from the maintenance phase of study NCT00705783 (31-07-246) and study NCT00706654 (31-07-247) and new participants. Participants received aripiprazole intramuscular (IM) depot as maintenance treatment.
Pre-assignment Details Study comprised of screening phase (applicable if enrolled late/new participants/received antipsychotic treatment other than aripiprazole), conversion phase (Phase 1, to convert from other antipsychotics to aripiprazole), oral stabilization phase (Phase 2-aripiprazole 10-30 mg), and open-label IM phase (Phase 3-aripiprazole 400 mg IM depot).
Arm/Group Title Aripiprazole 400/300 mg IM Depot
Hide Arm/Group Description Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
Period Title: Overall Study
Started 1081
Completed 858
Not Completed 223
Reason Not Completed
Lost to Follow-up             19
Met withdrawal criteria             24
Physician Decision             16
Withdrawal by Subject             89
Protocol deviation             1
Adverse Event             31
Lack of efficacy with AE             37
Lack of efficacy without AE             6
Arm/Group Title Aripiprazole 400/300 mg IM Depot
Hide Arm/Group Description Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
Overall Number of Baseline Participants 1081
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1081 participants
41.2  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1081 participants
Female
439
  40.6%
Male
642
  59.4%
1.Primary Outcome
Title Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).
Hide Description "Stable" was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here.
Time Frame Baseline to Week 52/Last visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week.
Arm/Group Title Aripiprazole 400/300 mg IM Depot
Hide Arm/Group Description:
Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
Overall Number of Participants Analyzed 1081
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline (N=1075) 100
Week 2 (N=1023) 99.02
Week 4 (N=1045) 99.14
Week 8 (N=1009) 98.51
Week 12 (N=988) 97.47
Week 16 (N=951) 98.42
Week 20 (N=919) 98.15
Week 24 (N=880) 99.20
Week 28 (N=854) 98.95
Week 32 (N=838) 99.16
Week 36 (N=814) 99.26
Week 40 (N=807) 99.50
Week 44 (N=784) 99.11
Week 48 (N=751) 99.20
Week 52 (N=671) 98.96
Last visit (N=1072) 94.96
2.Secondary Outcome
Title Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
Hide Description "Impending relapse criteria" was defined as meeting all the following criteria: 1) Clinical Global Impression of Improvement (CGI-I) ≥ 5 (minimally worse), AND an increase to score of >4 and absolute increase of ≥ 2 on the individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content); or an increase to score >4 and absolute increase of ≥ 4 on the combined 4 PANSS items on any of these PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) OR 2) Hospitalization due to worsening of psychotic symptoms, but excluding hospitalization for psychosocial reasons, OR 3) CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2, OR 4) Violent behavior resulting in clinically relevant self-injury, injury to another person, or property damage.
Time Frame Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week.
Arm/Group Title Aripiprazole 400/300 mg IM Depot
Hide Arm/Group Description:
Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
Overall Number of Participants Analyzed 1081
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 (N=1028) 0.49
Week 4 (N=1049) 0.48
Week 8 (N=1011) 0.79
Week 12 (N=988) 1.52
Week 16 (N=948) 0.84
Week 20 (N=920) 1.09
Week 24 (N=883) 0.45
Week 28 (N=857) 0.58
Week 32 (N=838) 0.36
Week 36 (N=814) 0.25
Week 40 (N=808) 0.25
Week 44 (N=783) 0.26
Week 48 (N=750) 0.27
Week 52 (N=668) 0.30
Last visit (N=1079) 4.17
Overall (N=1079) 8.25
3.Secondary Outcome
Title Percentage of Participants Achieving Remission.
Hide Description Remission is defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of six months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity.
Time Frame Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of participants evaluated at the specified trial week.
Arm/Group Title Aripiprazole 400/300 mg IM Depot
Hide Arm/Group Description:
Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
Overall Number of Participants Analyzed 1081
Measure Type: Number
Unit of Measure: Percentage of participants
51.7
4.Secondary Outcome
Title Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.
Hide Description "Stable" was defined as meeting all of the following criteria: Outpatient status; PANSS total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at Week 28 is described here.
Time Frame Baseline to Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. N defines number of stable participants at baseline who were evaluated at the specified trial week.
Arm/Group Title Aripiprazole 400/300 mg IM Depot
Hide Arm/Group Description:
Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
Overall Number of Participants Analyzed 1081
Measure Type: Number
Unit of Measure: Percentage of participants
Baseline (N=1075) 100
Week 28 (N=854) 98.95
5.Secondary Outcome
Title Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.
Hide Description Participants who first time meet relapse criteria were considered as having an event at date of exacerbation of psychotic symptoms/impending relapse. Time to first event was calculated as the earliest date of meeting one of relapse criteria. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed had available assessments for evaluation of exacerbation of psychotic symptoms/impending relapse.
Arm/Group Title Aripiprazole 400/300 mg IM Depot
Hide Arm/Group Description:
Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
Overall Number of Participants Analyzed 1079
Measure Type: Number
Unit of Measure: Percentage of participants
8.2
6.Secondary Outcome
Title Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.
Hide Description PANSS total score (range 30-210) is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS scale. PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
Time Frame Baseline, Weeks 12, 24, 52 and last visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.
Arm/Group Title Aripiprazole 400/300 mg IM Depot
Hide Arm/Group Description:
Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
Overall Number of Participants Analyzed 1081
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 (N=987) -1.69  (6.21)
Week 24 (N=882) -2.55  (7.08)
Week 52 (N=669) -3.55  (7.75)
Last visit (N=1078) -1.72  (10.21)
7.Secondary Outcome
Title Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.
Hide Description To assess CGI-S, the rater or physician will answer the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices include: 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 12, 24, 52 and last visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.
Arm/Group Title Aripiprazole 400/300 mg IM Depot
Hide Arm/Group Description:
Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
Overall Number of Participants Analyzed 1081
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 (N=987) -0.11  (0.52)
Week 24 (N=883) -0.17  (0.53)
Week 52 (N=668) -0.24  (0.56)
Last visit (N=1079) -0.14  (0.70)
8.Secondary Outcome
Title Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.
Hide Description PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. Positive subscale consists of 7 positive symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. Negative subscale consists of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
Time Frame Baseline, Weeks 12, 24, 52 and last visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.
Arm/Group Title Aripiprazole 400/300 mg IM Depot
Hide Arm/Group Description:
Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
Overall Number of Participants Analyzed 1081
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 positive subscale score (N=987) -0.42  (2.11)
Week 24 positive subscale score (N=882) -0.68  (2.26)
Week 52 positive subscale score (N=669) -1.04  (2.53)
Last visit positive subscale score (N=1078) -0.49  (3.38)
Week 12 negative subscale score (N=987) -0.40  (2.40)
Week 24 negative subscale score (N=882) -0.53  (2.52)
Week 52 negative subscale score (N=669) -0.80  (2.94)
Last visit negative subscale score (N=1078) -0.46  (3.19)
9.Secondary Outcome
Title Mean Clinical Global Impression of Improvement (CGI-I) Score.
Hide Description To assess CGI-I the rater or physician will rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses will be compared to the participants 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 Weeks 2, 4, 12, 24, 52 and last visit
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included. Number of participants analyzed with baseline or at least one postbaseline assessment are included here.
Arm/Group Title Aripiprazole 400/300 mg IM Depot
Hide Arm/Group Description:
Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
Overall Number of Participants Analyzed 1081
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (N=1081) 3.48  (0.82)
Week 2 (N=1026) 3.52  (0.85)
Week 4 (N=1049) 3.49  (0.86)
Week 12 (N=987) 3.42  (0.92)
Week 24 (N=882) 3.33  (0.98)
Week 52 (N=669) 3.25  (0.99)
Last visit (N=1079) 3.35  (1.10)
10.Secondary Outcome
Title Percentage of Participants Who Discontinued Due to All Causes.
Hide Description Participants who discontinued due to any cause were noted. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.
Time Frame Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered Phase 3 and have at least one post-baseline efficacy evaluation in Phase 3 are included.
Arm/Group Title Aripiprazole 400/300 mg IM Depot
Hide Arm/Group Description:
Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
Overall Number of Participants Analyzed 1081
Measure Type: Number
Unit of Measure: Percentage of participants
20.6
Time Frame Phase 3 Week 1 to Week 52/Early termination.
Adverse Event Reporting Description All participants who had received at least one dose of aripiprazole IM depot were included in safety analysis.
 
Arm/Group Title Aripiprazole 400/300 mg IM Depot
Hide Arm/Group Description Participants received open-label aripiprazole 400/300 mg IM depot into gluteal muscle every 4 weeks for a maximum of 52 weeks. Flexible dosing with apipiprazole 300 mg and 400 mg is permitted in order to maximize retention of participants. Partipants also received supplemental oral aripiprazole (10 mg to 20 mg daily) for the first two weeks to maintain therapeutic plasma concentrations.
All-Cause Mortality
Aripiprazole 400/300 mg IM Depot
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole 400/300 mg IM Depot
Affected / at Risk (%)
Total   95/1081 (8.79%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/1081 (0.09%) 
Cardiac disorders   
Atrial fibrillation * 1  1/1081 (0.09%) 
Cardiac arrest * 1  1/1081 (0.09%) 
Cardiac failure * 1  1/1081 (0.09%) 
Cardiac failure acute * 1  1/1081 (0.09%) 
Cardio-respiratory arrest * 1  1/1081 (0.09%) 
Myocardial infarction * 1  2/1081 (0.19%) 
Eye disorders   
Open angle glaucoma * 1  1/1081 (0.09%) 
Uveitis * 1  1/1081 (0.09%) 
Gastrointestinal disorders   
Dyspepsia * 1  1/1081 (0.09%) 
Oesophageal varices haemorrhage * 1  1/1081 (0.09%) 
Pancreatitis acute * 1  1/1081 (0.09%) 
Stomach mass * 1  1/1081 (0.09%) 
General disorders   
Facial pain * 1  1/1081 (0.09%) 
Sudden death * 1  1/1081 (0.09%) 
Hepatobiliary disorders   
Bile duct stone * 1  1/1081 (0.09%) 
Cholelithiasis * 1  2/1081 (0.19%) 
Infections and infestations   
Bronchitis * 1  2/1081 (0.19%) 
Cellulitis * 1  2/1081 (0.19%) 
Gangrene * 1  1/1081 (0.09%) 
Genital candidiasis * 1  1/1081 (0.09%) 
Hepatitis viral * 1  1/1081 (0.09%) 
Influenza * 1  1/1081 (0.09%) 
Pilonidal cyst * 1  1/1081 (0.09%) 
Pneumonia * 1  4/1081 (0.37%) 
Respiratory tract infection * 1  1/1081 (0.09%) 
Syphilis * 1  1/1081 (0.09%) 
Injury, poisoning and procedural complications   
Alcohol poisoning * 1  1/1081 (0.09%) 
Concussion * 1  1/1081 (0.09%) 
Hand fracture * 1  1/1081 (0.09%) 
Intentional overdose * 1  2/1081 (0.19%) 
Multiple injuries * 1  1/1081 (0.09%) 
Investigations   
Liver function test abnormal * 1  1/1081 (0.09%) 
Metabolism and nutrition disorders   
Dehydration * 1  2/1081 (0.19%) 
Hypoglycaemia * 1  1/1081 (0.09%) 
Hypovolaemia * 1  1/1081 (0.09%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer * 1  1/1081 (0.09%) 
Breast cancer recurrent * 1  1/1081 (0.09%) 
Haemangioma of liver * 1  1/1081 (0.09%) 
Non-small cell lung cancer metastatic * 1  1/1081 (0.09%) 
Rectal cancer metastatic * 1  1/1081 (0.09%) 
Tongue neoplasm * 1  1/1081 (0.09%) 
Nervous system disorders   
Convulsion * 1  1/1081 (0.09%) 
Loss of consciousness * 1  1/1081 (0.09%) 
Ruptured cerebral aneurysm * 1  1/1081 (0.09%) 
Tremor * 1  1/1081 (0.09%) 
Psychiatric disorders   
Adjustment disorder * 1  1/1081 (0.09%) 
Anxiety * 1  1/1081 (0.09%) 
Depression * 1  1/1081 (0.09%) 
Hallucination * 1  1/1081 (0.09%) 
Hallucination, auditory * 1  2/1081 (0.19%) 
Homicidal ideation * 1  1/1081 (0.09%) 
Psychotic disorder * 1  15/1081 (1.39%) 
Schizoaffective disorder * 1  1/1081 (0.09%) 
Schizophrenia * 1  21/1081 (1.94%) 
Schizophrenia, paranoid type * 1  5/1081 (0.46%) 
Suicidal ideation * 1  2/1081 (0.19%) 
Suicide attempt * 1  3/1081 (0.28%) 
Reproductive system and breast disorders   
Menorrhagia * 1  1/1081 (0.09%) 
Ovarian cyst * 1  1/1081 (0.09%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure * 1  1/1081 (0.09%) 
Asthma * 1  1/1081 (0.09%) 
Chronic obstructive pulmonary disease * 1  2/1081 (0.19%) 
Pneumothorax * 1  1/1081 (0.09%) 
Vascular disorders   
Arteriosclerosis * 1  1/1081 (0.09%) 
Hypertension * 1  1/1081 (0.09%) 
Hypotension * 1  1/1081 (0.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole 400/300 mg IM Depot
Affected / at Risk (%)
Total   254/1081 (23.50%) 
Infections and infestations   
Nasopharyngitis * 1  76/1081 (7.03%) 
Nervous system disorders   
Headache * 1  82/1081 (7.59%) 
Psychiatric disorders   
Anxiety * 1  73/1081 (6.75%) 
Insomnia * 1  71/1081 (6.57%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
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
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc
Phone: 800 562-3974
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00731549     History of Changes
Other Study ID Numbers: 31-08-248
First Submitted: August 5, 2008
First Posted: August 11, 2008
Results First Submitted: November 4, 2014
Results First Posted: November 11, 2014
Last Update Posted: November 26, 2014