A Phase 4 interventional study of Aripiprazole and Placebo in Schizophrenia and Insulin Resistance, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-06-23.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Treatment
This study will evaluate the effects of combination treatment with aripiprazole and clozapine on insulin resistance, blood fat levels, and weight gain in people diagnosed with schizophrenia.
Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations and delusions, as well as overall difficulty with everyday functioning. Although the medications available to treat the disorder are generally effective, many cause undesirable side effects. Clozapine, for example, is a strong tranquilizer that functions like an antipsychotic medication. It has been shown to be effective in reducing the symptoms of schizophrenia, but can bring about serious side effects, including heart failure, weight gain, and diabetes. Aripiprazole, an atypical antipsychotic medication, has been shown to have fewer side effects than older antipsychotic drugs. The addition of aripiprazole to a clozapine treatment regimen may reduce the negative side effects of clozapine. This study will evaluate the effects of combination treatment with aripiprazole and clozapine on insulin resistance, blood fat levels, and weight gain in people with schizophrenia.
Individuals interested in participating in this 8-week, double-blind study will first attend a screening session at the study site. Medical and psychiatric evaluations will be completed, blood samples will be taken, and an EKG will be performed. Eligible participants will undergo baseline assessments and then be randomly assigned to receive either aripiprazole or placebo in addition to their prescribed dose of clozapine. Participants will take one 15-mg capsule of their assigned medication once a day for 8 weeks. Study visits will occur biweekly for the first 8 weeks, followed by one final follow-up visit at Week 12. At each study visit, medication will be distributed, and the following criteria will be assessed: vital signs; weight; complete blood count; medication side effects; and extrapyramidal symptoms (EPS), which are potential neurological side effects of antipsychotic medications and may include involuntary movements, tremors, and rigidity. The Week 8 visit will include an EKG, and assessments of the following criteria: vital signs; medication side effects; treatment efficacy; blood counts; weight and height; and waist and hip circumference. At baseline and Week 8, participants will also undergo a frequently sampled intravenous glucose tolerance test (FSIVGTT). This involves intravenous infusion of glucose followed by frequent blood sampling to measure insulin and glucose concentrations. During the 4 days prior to each FSIVGTT, participants will record their food intake and wear an activity monitor.
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's enrollment of 38 is below the median of 70 across 2,924 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will take aripiprazole 15mg/day for 8 weeks.
Drug: Aripiprazole
Participants will take placebo for 8 weeks.
Drug: Placebo
15-mg dose once a day for 8 weeks
1 tablet placebo dose once a day for 8 weeks
Change in Total Cholesterol
A comparison of aripiprazole group and placebo group in change in total cholesterol measured at Baseline and Week 8.
Time frame: Measured at Baseline and Week 8
Change in Weight
A comparison between aripiprazole group and placebo group in change in weight measured at Baseline and Week 8.
Time frame: Measured at Baseline and Week 8
Change in Body Mass Index (BMI)
A comparison between aripiprazole group and placebo group of change in Body Mass Index (BMI) measured at Baseline and Week 8.
Time frame: Measured at Baseline and Week 8
Change in Glucose Metabolism
A comparison between the aripiprazole group and placebo group in change in glucose metabolism measured at Baseline and Week 8.
Time frame: Measured at Baseline and Week 8
Change in Triglycerides
Time frame: Measured at Baseline and Week 8
Change in Insulin Resistance
A comparison between aripiprazole group and placebo group of change in insulin resistance measured at Baseline and Week 8.
Time frame: Measured at Baseline and Week 8
Subjects were recruited from the Freedom Trail Clinic at the Erich Lindemann Mental Health Center and were studied at the General Clinical Research Center (GCRC) at the Massachusetts General Hospital (MGH), Boston and the Freedom Trail Clinic.
| Milestone | Aripiprazole | Placebo |
|---|---|---|
| Started | 20 | 18 |
| Completed | 16 | 14 |
| Not completed | 4 | 4 |
A comparison of aripiprazole group and placebo group in change in total cholesterol measured at Baseline and Week 8.
| mg/dL | Aripiprazole | Placebo |
|---|---|---|
| Change in Total Cholesterol | -15.3 ± 33.3 | 5.6 ± 34.0 |
A comparison between aripiprazole group and placebo group in change in weight measured at Baseline and Week 8.
| kg | Aripiprazole | Placebo |
|---|---|---|
| Change in Weight | -1.5 ± 2.3 | 0.3 ± 2.3 |
A comparison between aripiprazole group and placebo group of change in Body Mass Index (BMI) measured at Baseline and Week 8.
| kg/m^2 | Aripiprazole | Placebo |
|---|---|---|
| Change in Body Mass Index (BMI) | -0.52 ± 0.79 | 0.03 ± 0.85 |
A comparison between the aripiprazole group and placebo group in change in glucose metabolism measured at Baseline and Week 8.
| min^-1 | Aripiprazole | Placebo |
|---|---|---|
| Change in Glucose Metabolism | 0.003 ± 0.006 | -0.005 ± 0.007 |
| mg/dL | Aripiprazole | Placebo |
|---|---|---|
| Change in Triglycerides | -5.9 ± 75.1 | -7.3 ± 100.3 |
A comparison between aripiprazole group and placebo group of change in insulin resistance measured at Baseline and Week 8.
| HOMA score | Aripiprazole | Placebo |
|---|---|---|
| Change in Insulin Resistance | 0.6 ± 3.8 | 0.65 ± 1.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aripiprazole | — | 0/16 (0%) | 4/16 (25%) |
| Placebo | — | 0/14 (0%) | 3/14 (21.4%) |
| Event | Aripiprazole | Placebo |
|---|---|---|
| dizziness during IVGTT procedureGeneral disorders | 0/16 | 1/14 |
| asthmaRespiratory, thoracic and mediastinal disorders | 0/16 | 1/14 |
| stomach painGastrointestinal disorders | 0/16 | 1/14 |
| eye irritation/swellingEye disorders | 1/16 | 0/14 |
| psychiatric decompensationPsychiatric disorders | 1/16 | 0/14 |
| psychiatric decompensationPsychiatric disorders | 1/16 | 0/14 |
| psychiatric decompensationPsychiatric disorders | 1/16 | 0/14 |
| Age, Categorical(Participants) | Aripiprazole | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 18 | 38 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Aripiprazole | Placebo | Total |
|---|---|---|---|
| Mean | 44.3 ± 8.2 | 44.2 ± 8.9 | 44.25 ± 8.6 |
| Sex: Female, Male(Participants) | Aripiprazole | Placebo | Total |
|---|---|---|---|
| Female | 4 | 8 | 12 |
| Male | 16 | 10 | 26 |
| Region of Enrollment(participants) | Aripiprazole | Placebo | Total |
|---|---|---|---|
| United States | 20 | 18 | 38 |
The record gives a start of Mar 2005, a primary completion of Oct 2009 and a completion of Oct 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2012, 2 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Aripiprazole
Massachusetts General Hospital →