Trial Outcomes & Findings for Trial Comparing the Effects of Aripiprazole With Those of Standard of Care on Non-HDL Cholesterol in Patients With Schizophrenia or Bipolar I Disorder Who Have Metabolic Syndrome (NCT NCT00857818)

Last Updated: 2013-12-02

Results Overview

Based on Last Observation Carried Forward data. Non-HDL cholesterol is defined as the difference between total cholesterol and high-density lipoprotein (HDL) cholesterol levels. Fasting non-HDL cholesterol is defined as the measured fasting HDL cholesterol level subtracted from the measured fasting total cholesterol level.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

64 participants

Primary outcome timeframe

Baseline to Weeks 4, 8, and 16

Results posted on

2013-12-02

Participant Flow

Of 64 patients enrolled, 36 were screen failures, and 28 were randomized. Of those randomized, 26 received treatment.

Participant milestones

Participant milestones
Measure	Aripiprazole 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Control Group (Olanzapine, Risperidone, or Quetiapine) Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Overall Study STARTED	14	14
Overall Study Received Treatment	14	12
Overall Study COMPLETED	3	6
Overall Study NOT COMPLETED	11	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Aripiprazole 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Control Group (Olanzapine, Risperidone, or Quetiapine) Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Overall Study Lack of Efficacy	1	0
Overall Study Adverse Event	3	0
Overall Study Withdrawal by Subject	0	4
Overall Study Sponsor terminated study	6	4
Overall Study Investigator decision	1	0

Baseline Characteristics

Trial Comparing the Effects of Aripiprazole With Those of Standard of Care on Non-HDL Cholesterol in Patients With Schizophrenia or Bipolar I Disorder Who Have Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole n=14 Participants 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Control Group (Olanzapine, Risperidone, or Quetiapine) n=14 Participants Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.	Total n=28 Participants Total of all reporting groups
Age Continuous	39.0 years STANDARD_DEVIATION 10.36 • n=5 Participants	32.9 years STANDARD_DEVIATION 9.10 • n=7 Participants	35.9 years STANDARD_DEVIATION 10.06 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Weeks 4, 8, and 16

Population: All randomized patients who took at least 1 dose of study medication during the treatment period. The Last Observation Carried Forward (LOCF) data set included data recorded at a given visit. If no observation was recorded at that visit, data was carried forward from the previous visit. .

Outcome measures

Outcome measures
Measure	Aripiprazole n=13 Participants 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Control Group (Olanzapine, Risperidone, or Quetiapine) n=12 Participants Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels Week 4	-7.54 Percentage of change Standard Error 3.22	0.19 Percentage of change Standard Error 3.60
Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels Week 8	-18.45 Percentage of change Standard Error 2.37	-4.44 Percentage of change Standard Error 2.86
Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels Week 16	-14.72 Percentage of change Standard Error 3.86	-2.47 Percentage of change Standard Error 4.55

PRIMARY outcome

Timeframe: At baseline (Day 1)

Population: All randomized patients who took at least 1 dose of study medication during the treatment period.

Outcome measures

Outcome measures
Measure	Aripiprazole n=13 Participants 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Control Group (Olanzapine, Risperidone, or Quetiapine) n=12 Participants Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Mean Baseline Fasting Non-HDL Levels	176.07 mg/dL Standard Error 13.76	167.14 mg/dL Standard Error 14.01

SECONDARY outcome

Timeframe: Baseline to Week 16, continuously

Population: All randomized subjects who took at least 1 dose of study medication during the treatment period.

AE=any new untoward medical event or worsening of a preexisting medical condition that may or may not be causally related to treatment. SAE=any untoward medical occurrence that at any dose results in death; is life-threatening, a congenital anomaly/birth defect, or an important medical event; requires or prolongs inpatient hospitalization, or results in persistent or significant incapacity or drug dependency or abuse.

Outcome measures

Outcome measures
Measure	Aripiprazole n=14 Participants 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	Control Group (Olanzapine, Risperidone, or Quetiapine) n=14 Participants Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs Deaths	0 Participants	0 Participants
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs SAEs	2 Participants	0 Participants
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs AEs leading to discontinuation	3 Participants	0 Participants
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs 1 or more AEs	11 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 16

Population: Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 16

Population: Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

The CGI-S scale is a 7-point scale that requires the clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8, and 16

Population: Due to low enrollment, this study was terminated early, and these data were not summarized.

Any value falling outside of the normal range will be flagged for the attention of the investigator at the site. The investigator will indicate whether or not a flagged value is of clinical significance.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Weeks 4, 8, and 16

Population: Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

The IWQoL-Lite is a 31-item self-report survey that assesses the impact of weight on quality of life (QoL) in obese patients. Total score=the sum of scores(ranging from 1-5 for each item) for all 31 items. The sum is then rescaled to a 0-100 scoring, with 0 representing the poorest and 100 the best QoL. The survey also assesses improvements in QoL that occur with weight losses of 5% or greater and deteriorations in QoL with weight gain of 5% or greater. A change of 7.8 to 12.0 points from baseline=meaningful improvement. A change of -4.5 to -7.6 points from baseline=meaningful deterioration.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Weeks 4, 8, and 16

Population: Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Weeks 4, 8, and 16

Population: Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Weeks 4, 8. and 16

Population: Due to low enrollment, the study was terminated early. This endpoint was not analyzed because there were insufficient data to draw meaningful conclusions.

Outcome measures

Outcome data not reported

Adverse Events

ARIPIPRAZOLE

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

CONTROL GROUP

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ARIPIPRAZOLE n=14 participants at risk 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	CONTROL GROUP n=12 participants at risk Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Psychiatric disorders HALLUCINATION, VISUAL	7.1% 1/14	0.00% 0/12
Psychiatric disorders HALLUCINATION, AUDITORY	7.1% 1/14	0.00% 0/12
Psychiatric disorders PSYCHIATRIC DECOMPENSATION	7.1% 1/14	0.00% 0/12
Nervous system disorders NEUROLEPTIC MALIGNANT SYNDROME	7.1% 1/14	0.00% 0/12

Other adverse events

Other adverse events
Measure	ARIPIPRAZOLE n=14 participants at risk 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.	CONTROL GROUP n=12 participants at risk Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
Eye disorders VISION BLURRED	14.3% 2/14	0.00% 0/12
Investigations ALANINE AMINOTRANSFERASE INCREASED	7.1% 1/14	0.00% 0/12
Psychiatric disorders ANXIETY	14.3% 2/14	0.00% 0/12
Psychiatric disorders INSOMNIA	21.4% 3/14	0.00% 0/12
Psychiatric disorders AGITATION	7.1% 1/14	0.00% 0/12
Psychiatric disorders RESTLESSNESS	7.1% 1/14	0.00% 0/12
Psychiatric disorders HALLUCINATION, AUDITORY	7.1% 1/14	0.00% 0/12
Nervous system disorders TREMOR	21.4% 3/14	0.00% 0/12
Nervous system disorders HEADACHE	7.1% 1/14	0.00% 0/12
Nervous system disorders AKATHISIA	7.1% 1/14	0.00% 0/12
Nervous system disorders SOMNOLENCE	7.1% 1/14	8.3% 1/12
Nervous system disorders PARAESTHESIA	7.1% 1/14	0.00% 0/12
Nervous system disorders EXTRAPYRAMIDAL DISORDER	7.1% 1/14	0.00% 0/12
Gastrointestinal disorders NAUSEA	7.1% 1/14	8.3% 1/12
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/14	8.3% 1/12
Infections and infestations INFLUENZA	7.1% 1/14	0.00% 0/12
Infections and infestations TOOTH ABSCESS	7.1% 1/14	0.00% 0/12
Infections and infestations NASOPHARYNGITIS	7.1% 1/14	0.00% 0/12
Infections and infestations PHARYNGITIS STREPTOCOCCAL	7.1% 1/14	0.00% 0/12
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/14	16.7% 2/12
Metabolism and nutrition disorders DECREASED APPETITE	7.1% 1/14	0.00% 0/12
Metabolism and nutrition disorders INCREASED APPETITE	7.1% 1/14	0.00% 0/12
Injury, poisoning and procedural complications WOUND	0.00% 0/14	8.3% 1/12
Musculoskeletal and connective tissue disorders PAIN IN JAW	0.00% 0/14	8.3% 1/12
Musculoskeletal and connective tissue disorders MUSCLE RIGIDITY	7.1% 1/14	0.00% 0/12
Musculoskeletal and connective tissue disorders MUSCLE TWITCHING	7.1% 1/14	0.00% 0/12
Respiratory, thoracic and mediastinal disorders COUGH	7.1% 1/14	0.00% 0/12
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	7.1% 1/14	0.00% 0/12
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	7.1% 1/14	0.00% 0/12
Respiratory, thoracic and mediastinal disorders SPUTUM DISCOLOURED	7.1% 1/14	0.00% 0/12
General disorders FATIGUE	7.1% 1/14	8.3% 1/12
General disorders FEELING HOT	7.1% 1/14	0.00% 0/12
General disorders IRRITABILITY	7.1% 1/14	0.00% 0/12

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER