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Trial record 83 of 405 for:    ARIPIPRAZOLE

Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With 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: NCT01795547
Recruitment Status : Completed
First Posted : February 20, 2013
Results First Posted : December 3, 2015
Last Update Posted : March 17, 2017
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Aripiprazole and aripiprazole once-monthly
Drug: Paliperidone and paliperidone palmitate
Enrollment 295
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole Paliperidone
Hide Arm/Group Description Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24 Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
Period Title: Overall Study
Started 148 147
Completed 100 83
Not Completed 48 64
Reason Not Completed
Adverse Event             16             27
Lack of Efficacy             8             3
Protocol Violation             6             4
Lost to Follow-up             2             5
Withdrawal of consent             7             12
Not Treated             4             10
Non-compliance with IMP             1             1
Others             4             1
Not stated             0             1
Arm/Group Title Aripiprazole Paliperidone Total
Hide Arm/Group Description Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24 Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI Total of all reporting groups
Overall Number of Baseline Participants 148 147 295
Hide Baseline Analysis Population Description
Demographic data is based on all enrolled subjects, which were also all randomized
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 148 participants 147 participants 295 participants
42.6  (10.83) 41.0  (10.87) 41.8  (10.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 147 participants 295 participants
Female
59
  39.9%
59
  40.1%
118
  40.0%
Male
89
  60.1%
88
  59.9%
177
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 148 participants 147 participants 295 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.7%
3
   2.0%
4
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
44
  29.7%
38
  25.9%
82
  27.8%
White
102
  68.9%
102
  69.4%
204
  69.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.7%
4
   2.7%
5
   1.7%
1.Primary Outcome
Title Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score
Hide Description The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.
Arm/Group Title Aripiprazole Paliperidone
Hide Arm/Group Description:
Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
Overall Number of Participants Analyzed 136 132
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
7.47  (1.53) 2.80  (1.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole, Paliperidone
Comments Comparison of aripiprazole versus paliperidone was made using estimates from a mixed model for repeated measurements (MMRM) using an unstructured covariance matrix.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of the primary endpoint was considered confirmed if the lower bound of the 2-sided 95% CI at Week 28 was > -5 or equivalently if the p-value for the 1-sided test of H0: D ≤ -5 against H1: D > -5 was ≤2.5%, where D was the mean treatment difference (aripiprazole minus paliperidone). Superiority was then tested as pre-specified with the FAS and demonstrated for aripiprazole over paliperidone, since the lower bound of the 95% CI was >0.
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Mixed Models Analysis
Comments The model uses an unstructured variance/covariance matrix.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 4.666
Confidence Interval (2-Sided) 95%
0.316 to 9.015
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Investigator’s Assessment Questionnaire (IAQ) Total Score at Week 28
Hide Description The IAQ is a clinician-rated scale designed to assess the relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia or schizoaffective disorder. The IAQ consists of 12 items: positive symptoms, negative symptoms, other efficacy symptoms, cognition, energy, mood, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, EPS (other than akathisia) and other safety or tolerability issues. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (Much better) to 5 (Much worse), or that item is Not applicable. The sum of the 12 items ranged from 12 (the current medication was much better than previous antipsychotic medication) to 60 (the current medication was much worse than previous antipsychotic medication).
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 4, 8, 16, and 28. Since the IAQ was assessed from week 4, the analysis was based on 133 and 131 patients
Arm/Group Title Aripiprazole Paliperidone
Hide Arm/Group Description:
Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
Overall Number of Participants Analyzed 133 131
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
32.32  (0.52) 33.81  (0.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole, Paliperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity
Method Mixed Models Analysis
Comments The model uses an unstructured variance/covariance matrix.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.492
Confidence Interval (2-Sided) 95%
-2.935 to -0.049
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Week 28 in CGI-S Score
Hide Description Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.
Arm/Group Title Aripiprazole Paliperidone
Hide Arm/Group Description:
Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
Overall Number of Participants Analyzed 136 132
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.75  (0.07) -0.46  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole, Paliperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity
Method Mixed Models Analysis
Comments The model uses an unstructured variance/covariance matrix.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.283
Confidence Interval (2-Sided) 95%
-0.477 to -0.090
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score
Hide Description The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning.
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.
Arm/Group Title Aripiprazole Paliperidone
Hide Arm/Group Description:
Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
Overall Number of Participants Analyzed 136 132
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.52  (0.16) 0.18  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole, Paliperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.149
Comments All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity
Method Mixed Models Analysis
Comments The model uses an unstructured variance/covariance matrix.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.331
Confidence Interval (2-Sided) 95%
-0.120 to 0.782
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score
Hide Description The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning.
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.
Arm/Group Title Aripiprazole Paliperidone
Hide Arm/Group Description:
Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
Overall Number of Participants Analyzed 136 132
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.25  (0.59) 0.50  (0.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole, Paliperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity
Method Mixed Models Analysis
Comments The model uses an unstructured variance/covariance matrix.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.753
Confidence Interval (2-Sided) 95%
0.093 to 3.412
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score
Hide Description The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning.
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.
Arm/Group Title Aripiprazole Paliperidone
Hide Arm/Group Description:
Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
Overall Number of Participants Analyzed 136 132
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.24  (0.68) 1.47  (0.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole, Paliperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.070
Comments All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity
Method Mixed Models Analysis
Comments The model uses an unstructured variance/covariance matrix.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.764
Confidence Interval (2-Sided) 95%
-0.143 to 3.672
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score
Hide Description The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.
Arm/Group Title Aripiprazole Paliperidone
Hide Arm/Group Description:
Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
Overall Number of Participants Analyzed 136 132
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.76  (0.42) 0.83  (0.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole, Paliperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.130
Comments All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity
Method Mixed Models Analysis
Comments The model uses an unstructured variance/covariance matrix.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.922
Confidence Interval (2-Sided) 95%
-0.275 to 2.119
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline to Week 28 in SWN-S Total Score
Hide Description The SWN-S is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.
Arm/Group Title Aripiprazole Paliperidone
Hide Arm/Group Description:
Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
Overall Number of Participants Analyzed 136 132
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.82  (1.24) 3.81  (1.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole, Paliperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.561
Comments All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity
Method Mixed Models Analysis
Comments The model uses an unstructured variance/covariance matrix.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.007
Confidence Interval (2-Sided) 95%
-2.402 to 4.417
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to Week 28 in the TooL Total Score
Hide Description Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).
Time Frame Baseline, Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.
Arm/Group Title Aripiprazole Paliperidone
Hide Arm/Group Description:
Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
Overall Number of Participants Analyzed 136 132
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.75  (0.30) -1.05  (0.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole, Paliperidone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity
Method Mixed Models Analysis
Comments The model uses an unstructured variance/covariance matrix.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.695
Confidence Interval (2-Sided) 95%
-1.511 to 0.121
Estimation Comments [Not Specified]
Time Frame First dose to end of study (32 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ARIPIPRAZOLE PALIPERIDONE
Hide Arm/Group Description Safety data is based on all patients who received study medicine. Safety data is based on all patients who received study medicine.
All-Cause Mortality
ARIPIPRAZOLE PALIPERIDONE
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ARIPIPRAZOLE PALIPERIDONE
Affected / at Risk (%) Affected / at Risk (%)
Total   12/144 (8.33%)   10/137 (7.30%) 
Hepatobiliary disorders     
Cirrhosis alcoholic  1  0/144 (0.00%)  1/137 (0.73%) 
Infections and infestations     
Gastroenteritis viral  1  0/144 (0.00%)  1/137 (0.73%) 
Injury, poisoning and procedural complications     
Head injury  1  0/144 (0.00%)  1/137 (0.73%) 
Intentional overdose  1  1/144 (0.69%)  0/137 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Nasopharyngeal cancer  1  0/144 (0.00%)  1/137 (0.73%) 
Psychiatric disorders     
Psychotic disorder  1  5/144 (3.47%)  4/137 (2.92%) 
Schizophrenia  1  5/144 (3.47%)  1/137 (0.73%) 
Suividal ideation  1  1/144 (0.69%)  0/137 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/144 (0.00%)  1/137 (0.73%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ARIPIPRAZOLE PALIPERIDONE
Affected / at Risk (%) Affected / at Risk (%)
Total   64/144 (44.44%)   74/137 (54.01%) 
Gastrointestinal disorders     
Nausea  1  3/144 (2.08%)  8/137 (5.84%) 
General disorders     
Fatigue  1  4/144 (2.78%)  7/137 (5.11%) 
Injection site pain  1  4/144 (2.78%)  11/137 (8.03%) 
Infections and infestations     
Nasopharyngitis  1  6/144 (4.17%)  8/137 (5.84%) 
Injury, poisoning and procedural complications     
Accidental overdose  1 [1]  30/144 (20.83%)  13/137 (9.49%) 
Investigations     
Weight increased  1  13/144 (9.03%)  19/137 (13.87%) 
Nervous system disorders     
Akathisia  1  8/144 (5.56%)  6/137 (4.38%) 
Dizziness  1  5/144 (3.47%)  12/137 (8.76%) 
Headache  1  3/144 (2.08%)  11/137 (8.03%) 
Somnolence  1  9/144 (6.25%)  8/137 (5.84%) 
Psychiatric disorders     
Anxiety  1  8/144 (5.56%)  12/137 (8.76%) 
Insomnia  1  17/144 (11.81%)  17/137 (12.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA16.1
[1]
these events occurred during the oral treatment phase of the study
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: Study director
Organization: Email contact via H. Ludbeck A/S
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01795547     History of Changes
Other Study ID Numbers: 14724A
2012-002785-12 ( EudraCT Number )
First Submitted: February 18, 2013
First Posted: February 20, 2013
Results First Submitted: September 17, 2015
Results First Posted: December 3, 2015
Last Update Posted: March 17, 2017