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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01739127
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : May 25, 2016
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment
Psychotic Disorders Bipolar Disorder Metabolic Syndrome X Drug: Aripiprazole Drug: Risperidone/Quetiapine

Detailed 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.

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Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Longitudinal Comparison of Aripiprazole vs. Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI
Study Start Date : November 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Group/Cohort Intervention/treatment
Participants receiving treatment with at least 10mg aripiprazole per day, as prescribed to them by their psychiatrists.
Drug: Aripiprazole
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
Other Name: ABILIFY

Participants receiving treatment with either risperidone or quetiapine, as prescribed to them by their psychiatrists.
Drug: Risperidone/Quetiapine
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
Other Names:
  • Risperdal
  • Apo-risperidone
  • Seroquel
  • Apo-quetiapine

Healthy participants who are not taking any antipsychotic medications.

Primary Outcome Measures :
  1. Abdominal distribution of visceral fat versus subcutaneous fat [ Time Frame: Baseline (within 12 weeks of starting antipsychotic treatment), and 16 weeks later ]
    Change over time, and between groups, in amounts of visceral and subcutaneous fat as measured by automated segmentation of a magnetic resonance image (MRI).

Secondary Outcome Measures :
  1. Fat content of the liver [ Time Frame: Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later ]
    Change over time, and between groups, in the amount of fat accumulation in the liver as measured by magnetic resonance spectroscopy (MRS).

  2. Metabolic measures [ Time Frame: Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later ]
    Comparing change in the levels of hemoglobin, fasting lipid levels, adiponectin, leptin, insulin, and glucagon-like peptide 1 (GLP-1).

  3. Glucose intolerance [ Time Frame: Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later ]
    Change over time, and between groups, in ability to tolerate a glucose challenge as measured by an oral glucose tolerance test (OGTT).

  4. Potential genetic factors of antipsychotic-induced weight gain [ Time Frame: Sample to be taken after 16 weeks of participation in the study ]
    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.

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01739127

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Canada, British Columbia
BC Mental Health & Addictions Research Institute
Vancouver, British Columbia, Canada, V5Z 4H4
Sponsors and Collaborators
University of British Columbia
Bristol-Myers Squibb
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Principal Investigator: Alasdair M Barr, Ph.D. The University of British Columbia

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Responsible Party: University of British Columbia Identifier: NCT01739127    
Other Study ID Numbers: H12-01611
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016
Keywords provided by University of British Columbia:
Antipsychotic agents
Adverse effects
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Metabolic Syndrome
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Bipolar and Related Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists