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

NCT01739127 | Completed

• 1 other identifier: H12-01611
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychotic Disorders; Bipolar Disorder; Metabolic Syndrome X

Keywords

Antipsychotic agents; Adverse effects; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Fat content of the liver

  Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later

• Metabolic measures

  Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later

• Glucose intolerance

  Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later

• Potential genetic factors of antipsychotic-induced weight gain

  Sample to be taken after 16 weeks of participation in the study

Study Arms (3)

Aripiprazole

Participants receiving treatment with at least 10mg aripiprazole per day, as prescribed to them by their psychiatrists.

Drug: Aripiprazole

Risperidone/Quetiapine

Participants receiving treatment with either risperidone or quetiapine, as prescribed to them by their psychiatrists.

Drug: Risperidone/Quetiapine

Control

Healthy participants who are not taking any antipsychotic medications.

Interventions

Aripiprazole DRUG

To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).

Also known as: ABILIFY

Aripiprazole

Risperidone/Quetiapine DRUG

To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).

Also known as: Risperdal, Apo-risperidone, Seroquel, Apo-quetiapine

Risperidone/Quetiapine

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who have recently been seen at a community Early Psychosis Intervention (EPI) clinic, or at BC Children's Hospital for first-episode psychosis or bipolar disorder. Age-, sex-, and weight-matched controls will be recruited from the general community.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of British Columbia: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

BC Mental Health & Addictions Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Participants will be offered the option of taking part in an optional biobanking component of the main study. Six milliliters of whole blood samples will be collected and stored at -80 degrees Celsius for genotyping to determine if certain genetic polymorphisms predispose individuals to gain weight while taking antipsychotic medications.

MeSH Terms

Conditions

Psychotic Disorders; Bipolar Disorder; Metabolic Syndrome

Interventions

Aripiprazole; Risperidone; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidinones; Pyrimidines; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring

Study Officials

• Alasdair M Barr, Ph.D.

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 3, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

CA (1)