Trial Outcomes & Findings for Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia (NCT NCT01795547)
NCT ID: NCT01795547
Last Updated: 2017-03-17
Results Overview
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.
COMPLETED
PHASE3
295 participants
Baseline, Week 28
2017-03-17
Participant Flow
Participant milestones
| Measure |
Aripiprazole
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
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 Study
STARTED
|
148
|
147
|
|
Overall Study
COMPLETED
|
100
|
83
|
|
Overall Study
NOT COMPLETED
|
48
|
64
|
Reasons for withdrawal
| Measure |
Aripiprazole
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
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 Study
Adverse Event
|
16
|
27
|
|
Overall Study
Lack of Efficacy
|
8
|
3
|
|
Overall Study
Protocol Violation
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Withdrawal of consent
|
7
|
12
|
|
Overall Study
Not Treated
|
4
|
10
|
|
Overall Study
Non-compliance with IMP
|
1
|
1
|
|
Overall Study
Others
|
4
|
1
|
|
Overall Study
Not stated
|
0
|
1
|
Baseline Characteristics
Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Aripiprazole
n=148 Participants
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
n=147 Participants
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
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 10.83 • n=93 Participants
|
41.0 years
STANDARD_DEVIATION 10.87 • n=4 Participants
|
41.8 years
STANDARD_DEVIATION 10.86 • n=27 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=93 Participants
|
88 Participants
n=4 Participants
|
177 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
44 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
204 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 28Population: 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.
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.
Outcome measures
| Measure |
Aripiprazole
n=136 Participants
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.
|
Paliperidone
n=132 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score
|
7.47 units on a scale
Standard Error 1.53
|
2.80 units on a scale
Standard Error 1.62
|
SECONDARY outcome
Timeframe: Week 28Population: 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
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).
Outcome measures
| Measure |
Aripiprazole
n=133 Participants
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.
|
Paliperidone
n=131 Participants
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.
|
|---|---|---|
|
Investigator's Assessment Questionnaire (IAQ) Total Score at Week 28
|
32.32 units on a scale
Standard Error 0.52
|
33.81 units on a scale
Standard Error 0.55
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: 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.
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).
Outcome measures
| Measure |
Aripiprazole
n=136 Participants
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.
|
Paliperidone
n=132 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 28 in CGI-S Score
|
-0.75 units on a scale
Standard Error 0.07
|
-0.46 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: 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.
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.
Outcome measures
| Measure |
Aripiprazole
n=136 Participants
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.
|
Paliperidone
n=132 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score
|
0.52 units on a scale
Standard Error 0.16
|
0.18 units on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: 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.
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.
Outcome measures
| Measure |
Aripiprazole
n=136 Participants
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.
|
Paliperidone
n=132 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score
|
2.25 units on a scale
Standard Error 0.59
|
0.50 units on a scale
Standard Error 0.63
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: 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.
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.
Outcome measures
| Measure |
Aripiprazole
n=136 Participants
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.
|
Paliperidone
n=132 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score
|
3.24 units on a scale
Standard Error 0.68
|
1.47 units on a scale
Standard Error 0.72
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: 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.
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.
Outcome measures
| Measure |
Aripiprazole
n=136 Participants
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.
|
Paliperidone
n=132 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score
|
1.76 units on a scale
Standard Error 0.42
|
0.83 units on a scale
Standard Error 0.45
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: 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.
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.
Outcome measures
| Measure |
Aripiprazole
n=136 Participants
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.
|
Paliperidone
n=132 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 28 in SWN-S Total Score
|
4.82 units on a scale
Standard Error 1.24
|
3.81 units on a scale
Standard Error 1.31
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: 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.
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).
Outcome measures
| Measure |
Aripiprazole
n=136 Participants
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.
|
Paliperidone
n=132 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 28 in the TooL Total Score
|
-1.75 units on a scale
Standard Error 0.30
|
-1.05 units on a scale
Standard Error 0.32
|
Adverse Events
ARIPIPRAZOLE
PALIPERIDONE
Serious adverse events
| Measure |
ARIPIPRAZOLE
n=144 participants at risk
Safety data is based on all patients who received study medicine.
|
PALIPERIDONE
n=137 participants at risk
Safety data is based on all patients who received study medicine.
|
|---|---|---|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/144 • First dose to end of study (32 weeks)
|
0.73%
1/137 • First dose to end of study (32 weeks)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/144 • First dose to end of study (32 weeks)
|
0.73%
1/137 • First dose to end of study (32 weeks)
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/144 • First dose to end of study (32 weeks)
|
0.73%
1/137 • First dose to end of study (32 weeks)
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.69%
1/144 • First dose to end of study (32 weeks)
|
0.00%
0/137 • First dose to end of study (32 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.00%
0/144 • First dose to end of study (32 weeks)
|
0.73%
1/137 • First dose to end of study (32 weeks)
|
|
Psychiatric disorders
Psychotic disorder
|
3.5%
5/144 • First dose to end of study (32 weeks)
|
2.9%
4/137 • First dose to end of study (32 weeks)
|
|
Psychiatric disorders
Schizophrenia
|
3.5%
5/144 • First dose to end of study (32 weeks)
|
0.73%
1/137 • First dose to end of study (32 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/144 • First dose to end of study (32 weeks)
|
0.73%
1/137 • First dose to end of study (32 weeks)
|
|
Psychiatric disorders
Suividal ideation
|
0.69%
1/144 • First dose to end of study (32 weeks)
|
0.00%
0/137 • First dose to end of study (32 weeks)
|
Other adverse events
| Measure |
ARIPIPRAZOLE
n=144 participants at risk
Safety data is based on all patients who received study medicine.
|
PALIPERIDONE
n=137 participants at risk
Safety data is based on all patients who received study medicine.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.1%
3/144 • First dose to end of study (32 weeks)
|
5.8%
8/137 • First dose to end of study (32 weeks)
|
|
General disorders
Fatigue
|
2.8%
4/144 • First dose to end of study (32 weeks)
|
5.1%
7/137 • First dose to end of study (32 weeks)
|
|
General disorders
Injection site pain
|
2.8%
4/144 • First dose to end of study (32 weeks)
|
8.0%
11/137 • First dose to end of study (32 weeks)
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
6/144 • First dose to end of study (32 weeks)
|
5.8%
8/137 • First dose to end of study (32 weeks)
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
20.8%
30/144 • First dose to end of study (32 weeks)
|
9.5%
13/137 • First dose to end of study (32 weeks)
|
|
Investigations
Weight increased
|
9.0%
13/144 • First dose to end of study (32 weeks)
|
13.9%
19/137 • First dose to end of study (32 weeks)
|
|
Nervous system disorders
Akathisia
|
5.6%
8/144 • First dose to end of study (32 weeks)
|
4.4%
6/137 • First dose to end of study (32 weeks)
|
|
Nervous system disorders
Dizziness
|
3.5%
5/144 • First dose to end of study (32 weeks)
|
8.8%
12/137 • First dose to end of study (32 weeks)
|
|
Nervous system disorders
Headache
|
2.1%
3/144 • First dose to end of study (32 weeks)
|
8.0%
11/137 • First dose to end of study (32 weeks)
|
|
Nervous system disorders
Somnolence
|
6.2%
9/144 • First dose to end of study (32 weeks)
|
5.8%
8/137 • First dose to end of study (32 weeks)
|
|
Psychiatric disorders
Anxiety
|
5.6%
8/144 • First dose to end of study (32 weeks)
|
8.8%
12/137 • First dose to end of study (32 weeks)
|
|
Psychiatric disorders
Insomnia
|
11.8%
17/144 • First dose to end of study (32 weeks)
|
12.4%
17/137 • First dose to end of study (32 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place