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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of British Columbia
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01739127
First received: November 27, 2012
Last updated: July 28, 2014
Last verified: July 2014

November 27, 2012
July 28, 2014
November 2012
November 2014   (final data collection date for primary outcome measure)
Abdominal distribution of visceral fat versus subcutaneous fat [ Time Frame: Baseline (within 12 weeks of starting antipsychotic treatment), and 16 weeks later ] [ Designated as safety issue: No ]
Change over time, and between groups, in amounts of visceral and subcutaneous fat as measured by automated segmentation of a magnetic resonance image (MRI).
Same as current
Complete list of historical versions of study NCT01739127 on ClinicalTrials.gov Archive Site
  • Fat content of the liver [ Time Frame: Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later ] [ Designated as safety issue: No ]
    Change over time, and between groups, in the amount of fat accumulation in the liver as measured by magnetic resonance spectroscopy (MRS).
  • Metabolic measures [ Time Frame: Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later ] [ Designated as safety issue: No ]
    Comparing change in the levels of hemoglobin, fasting lipid levels, adiponectin, leptin, insulin, and glucagon-like peptide 1 (GLP-1).
  • Glucose intolerance [ Time Frame: Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later ] [ Designated as safety issue: No ]
    Change over time, and between groups, in ability to tolerate a glucose challenge as measured by an oral glucose tolerance test (OGTT).
  • Potential genetic factors of antipsychotic-induced weight gain [ Time Frame: Sample to be taken after 16 weeks of participation in the study ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Comparison of Aripiprazole Versus Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI
A Longitudinal Comparison of Aripiprazole vs. Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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.

  • Psychotic Disorders
  • Bipolar Disorder
  • Metabolic Syndrome X
  • 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
  • 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
  • Aripiprazole
    Participants receiving treatment with at least 10mg aripiprazole per day, as prescribed to them by their psychiatrists.
    Intervention: Drug: Aripiprazole
  • Risperidone/Quetiapine
    Participants receiving treatment with either risperidone or quetiapine, as prescribed to them by their psychiatrists.
    Intervention: Drug: Risperidone/Quetiapine
  • Control
    Healthy participants who are not taking any antipsychotic medications.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
November 2014
November 2014   (final data collection date for primary outcome measure)

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.).
Both
12 Years and older
Yes
Contact: Lurdes Tse, M.Sc. 604-875-2000 ext 6115 lurdes@mail.ubc.ca
Contact: Heidi N Boyda 604-612-5025 hnboyda@gmail.com
Canada
 
NCT01739127
H12-01611
No
University of British Columbia
University of British Columbia
Bristol-Myers Squibb
Principal Investigator: Alasdair M Barr, Ph.D. The University of British Columbia
University of British Columbia
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP