Trial Outcomes & Findings for Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder (NCT NCT00423878)

Last Updated: 2016-11-02

Results Overview

Change in non-HDL cholesterol measured at baseline and every 4 weeks for 24 weeks. The efficacy analysis corresponded to a comparison of change in non-HDL cholesterol from baseline to 24 weeks between treatment groups (stay versus switch). Repeated measurements mixed effects linear models were fit for the primary analysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

215 participants

Primary outcome timeframe

24 weeks

Results posted on

2016-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Switch Group Participants will switch to aripiprazole with a cross-titration from the current antipsychotic over 3-4 weeks. Allowed final dosage range for aripiprazole was 5-30 mg/day.	Stay Group Participants will continue with their current antipsychotic treatment, either olanzapine 5-20 mg/day, quetiapine 200-1200 mg/day, or risperidone 1-16 mg/day.
Overall Study STARTED	109	106
Overall Study COMPLETED	89	98
Overall Study NOT COMPLETED	20	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Switch Group n=109 Participants Participants will switch to aripiprazole.	Stay Group n=106 Participants Participants will continue treatment with olanzapine, quetiapine, or risperidone.	Total n=215 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	109 Participants n=5 Participants	106 Participants n=7 Participants	215 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40 years STANDARD_DEVIATION 11.7 • n=5 Participants	42 years STANDARD_DEVIATION 10.5 • n=7 Participants	41 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	37 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	69 Participants n=7 Participants	137 Participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants	106 participants n=7 Participants	215 participants n=5 Participants
non-HDL cholesterol	169 mg/dL STANDARD_DEVIATION 31.9 • n=5 Participants	176 mg/dL STANDARD_DEVIATION 33.5 • n=7 Participants	173 mg/dL STANDARD_DEVIATION 32.8 • n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: The primary efficacy analysis was conducted on the efficacy evaluable population, defined as all patients randomly assigned to a study group who received at least one dose of study medication and completed at least one post-baseline efficacy assessment.

Outcome measures

Outcome measures
Measure	Switch Group n=89 Participants Participants will switch to aripiprazole.	Stay Group n=98 Participants Participants will continue treatment with olanzapine, quetiapine, or risperidone.
Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks	-20.2 mg/dL non-HDL cholesterol Standard Error 2.87	-10.8 mg/dL non-HDL cholesterol Standard Error 2.57

SECONDARY outcome

Timeframe: Measured at Month 6

Population: 2 participants who never took assigned study medication were excluded.

Outcome measures

Outcome measures
Measure	Switch Group n=107 Participants Participants will switch to aripiprazole.	Stay Group n=106 Participants Participants will continue treatment with olanzapine, quetiapine, or risperidone.
Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C)	22 participants	18 participants

Adverse Events

Switch Group

Serious events: 18 serious events

Other events: 77 other events

Deaths: 0 deaths

Stay Group

Serious events: 9 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Switch Group n=107 participants at risk Participants will switch to aripiprazole.	Stay Group n=106 participants at risk Participants will continue treatment with olanzapine, quetiapine, or risperidone.
Psychiatric disorders Exacerbation of schizophrenia	8.4% 9/107 • Number of events 11 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	2.8% 3/106 • Number of events 4 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.93% 1/107 • Number of events 1 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	0.94% 1/106 • Number of events 1 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Cardiac disorders Syncope	0.00% 0/107 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	0.94% 1/106 • Number of events 1 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
General disorders Slurred speech/sedation	0.93% 1/107 • Number of events 2 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	0.00% 0/106 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Psychiatric disorders Suicidality	0.00% 0/107 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	1.9% 2/106 • Number of events 2 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Psychiatric disorders Agitation	0.93% 1/107 • Number of events 2 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	0.00% 0/106 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Blood and lymphatic system disorders Agranulocytosis	0.93% 1/107 • Number of events 1 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	0.00% 0/106 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Gastrointestinal disorders Gastroenteritis	0.93% 1/107 • Number of events 1 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	0.00% 0/106 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
General disorders Accidental overdose	0.93% 1/107 • Number of events 1 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	0.94% 1/106 • Number of events 1 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Nervous system disorders Neuropathic pain	0.93% 1/107 • Number of events 1 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	0.00% 0/106 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
General disorders Victim of gunshot wound	0.93% 1/107 • Number of events 1 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	0.00% 0/106 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
General disorders	0.93% 1/107 • Number of events 1 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	0.94% 1/106 • Number of events 1 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.

Other adverse events

Additional Information

Dr. Scott Stroup

Columbia University

Phone: 212-543-5676

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Switch Group n=107 participants at risk Participants will switch to aripiprazole.	Stay Group n=106 participants at risk Participants will continue treatment with olanzapine, quetiapine, or risperidone.
Psychiatric disorders Insomnia	41.1% 44/107 • Number of events 44 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	27.4% 29/106 • Number of events 29 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Psychiatric disorders Sleepiness	25.2% 27/107 • Number of events 27 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	33.0% 35/106 • Number of events 35 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Gastrointestinal disorders Dry mouth	22.4% 24/107 • Number of events 24 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	34.0% 36/106 • Number of events 36 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Nervous system disorders Akathisia/activation	27.1% 29/107 • Number of events 29 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	24.5% 26/106 • Number of events 26 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Endocrine disorders Problems with sex drive	22.4% 24/107 • Number of events 24 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	24.5% 26/106 • Number of events 26 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
General disorders Increased appetite	16.8% 18/107 • Number of events 18 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	24.5% 26/106 • Number of events 26 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
General disorders Weight gain	18.7% 20/107 • Number of events 20 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	19.8% 21/106 • Number of events 21 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Gastrointestinal disorders Constipation	18.7% 20/107 • Number of events 20 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	18.9% 20/106 • Number of events 20 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Nervous system disorders Akinesia	13.1% 14/107 • Number of events 14 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	23.6% 25/106 • Number of events 25 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Endocrine disorders Problems with sexual orgasm	18.7% 20/107 • Number of events 20 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	17.9% 19/106 • Number of events 19 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Endocrine disorders Problems with sexual arousal	18.7% 20/107 • Number of events 20 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	17.0% 18/106 • Number of events 18 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
General disorders Hypersomnia	15.0% 16/107 • Number of events 16 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	19.8% 21/106 • Number of events 21 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
General disorders Orthostatic faintness	17.8% 19/107 • Number of events 19 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	17.0% 18/106 • Number of events 18 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Gastrointestinal disorders Nausea	11.2% 12/107 • Number of events 12 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	17.0% 18/106 • Number of events 18 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Renal and urinary disorders Incontinence/nocturia	8.4% 9/107 • Number of events 9 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	12.3% 13/106 • Number of events 13 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Skin and subcutaneous tissue disorders Skin rash	7.5% 8/107 • Number of events 8 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	11.3% 12/106 • Number of events 12 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Endocrine disorders Menstrual irregularities	9.3% 10/107 • Number of events 10 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	5.7% 6/106 • Number of events 6 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
General disorders Sialorrhea	7.5% 8/107 • Number of events 8 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	6.6% 7/106 • Number of events 7 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Renal and urinary disorders Urinary hesistancy	4.7% 5/107 • Number of events 5 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	3.8% 4/106 • Number of events 4 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.
Endocrine disorders Gynecomastia/galactorrhea	1.9% 2/107 • Number of events 2 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.	3.8% 4/106 • Number of events 4 Two participants randomized to switch to aripiprazole withdrew from the study before taking the study medication.