Comparison of Aripiprazole Versus Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI

Bipolar Disorder Clinical Trial

— CALM  

Official title:

A Longitudinal Comparison of Aripiprazole vs. Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739127
• Other study ID #: H12-01611
• Status: Completed
• Phase: N/A
• First received: November 27, 2012
• Last updated: May 24, 2016
• Start date: November 2012
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to compare abdominal weight gain and fat distribution in people taking aripiprazole versus risperidone or quetiapine, to people not taking any of these antipsychotic medications.

Description:

Second generation antipsychotic drugs have much greater efficacy for refractory schizophrenia and have much lower propensity to induce motor side-effects. These medications are seeing increased use for indications other than psychosis, and greater use in populations such as adolescents. However, one of the most critical issues in the field of psychiatry today is the overwhelming evidence that chronic use of the second generation antipsychotics can result in metabolic dysregulation, which includes weight gain, hyperlipidemia, and insulin resistance. A recent meta-analysis indicated that switching from other second generation antipsychotics to the antipsychotic drug aripiprazole consistently resulted in significant weight loss and may be an optimal treatment for patients who exhibit drug-induced weight gain. Therefore, we aim to compare metabolic dysregulation (namely abdominal weight gain and fat distribution)in participants taking aripiprazole, to participants who are taking higher-metabolic propensity antipsychotic drugs (such as risperidone or quetiapine), and to healthy participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Male or female, aged 12+ years for healthy participants or participants with bipolar disorder; or aged 15+ years for participants with non-affective psychosis.

• Recent admission to hospital for psychiatric services related to first-episode psychosis or first-episode bipolar disorder.

• Participants being treated with an antipsychotic medication principally for psychosis or for bipolar disorder.

• Participants taking aripiprazole must be taking a dose of at least 10mg/day for the duration of the study.

• Participants must have received no more than 12 weeks of total lifetime exposure to antipsychotics.

• Participants may be in- or outpatients.

• Participants able to give informed consent, or informed consent through legally authorized representative.

Exclusion Criteria:

• Previous total lifetime exposure to antipsychotics of more than 12 weeks.

• Previously diagnosed with diabetes mellitus, seizure disorders, mental retardation (IQ < 70), or pregnancy (current or within 3 months postpartum).

• Participants who have been treated/are currently being treated with mood stabilizers (paroxetine, lithium, or valproic acid). Prior or concurrent use of Selective Serotonin Reuptake Inhibitor antidepressants (other than paroxetine) is acceptable.

• Received chemotherapy for cancer treatment in the 4 weeks prior to baseline or 16-week follow-up visit.

• Participants who are not able to fluently communicate in English.

• Contraindicated for MRI scan (i.e., has had major surgery in the last 6 months, morbid obesity, claustrophobia, and/or has metal in their bodies from a surgical intervention or working in metalwork, or is unsure if metal is present in their bodies, etc.).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Metabolic Syndrome X
• Psychotic Disorders

Intervention

Drug:
• Aripiprazole
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
• Risperidone/Quetiapine
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).

Locations

Country	Name	City	State
Canada	BC Mental Health & Addictions Research Institute	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Bristol-Myers Squibb

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal distribution of visceral fat versus subcutaneous fat	Change over time, and between groups, in amounts of visceral and subcutaneous fat as measured by automated segmentation of a magnetic resonance image (MRI).	Baseline (within 12 weeks of starting antipsychotic treatment), and 16 weeks later	No
Secondary	Fat content of the liver	Change over time, and between groups, in the amount of fat accumulation in the liver as measured by magnetic resonance spectroscopy (MRS).	Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later	No
Secondary	Metabolic measures	Comparing change in the levels of hemoglobin, fasting lipid levels, adiponectin, leptin, insulin, and glucagon-like peptide 1 (GLP-1).	Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later	No
Secondary	Glucose intolerance	Change over time, and between groups, in ability to tolerate a glucose challenge as measured by an oral glucose tolerance test (OGTT).	Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later	No
Secondary	Potential genetic factors of antipsychotic-induced weight gain	DNA will be extracted and amplified using polymerase chain reaction (PCR), and the presence or absence of certain single nucleotide polymorphisms will be identified by using primers.	Sample to be taken after 16 weeks of participation in the study	No