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
  Purpose

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 Intervention
Psychotic Disorders
Bipolar Disorder
Metabolic Syndrome X
Drug: Aripiprazole
Drug: Risperidone/Quetiapine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Longitudinal Comparison of Aripiprazole vs. Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


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.


Estimated Enrollment: 90
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Aripiprazole
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
Risperidone/Quetiapine
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
Control
Healthy participants who are not taking any antipsychotic medications.

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739127

Contacts
Contact: Lurdes Tse, M.Sc. 604-875-2000 ext 6115 lurdes@mail.ubc.ca
Contact: Heidi N Boyda 604-612-5025 hnboyda@gmail.com

Locations
Canada, British Columbia
BC Mental Health & Addictions Research Institute Recruiting
Vancouver, British Columbia, Canada, V5Z 4H4
Contact: Lurdes Tse, M.Sc.    604-875-2000 ext 6115    lurdes@mail.ubc.ca   
Contact: Heidi N Boyda    604-612-5025    hnboyda@gmail.com   
Principal Investigator: Alasdair M Barr, Ph.D.         
Sponsors and Collaborators
University of British Columbia
Bristol-Myers Squibb
Investigators
Principal Investigator: Alasdair M Barr, Ph.D. The University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01739127     History of Changes
Other Study ID Numbers: H12-01611
Study First Received: November 27, 2012
Last Updated: July 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Antipsychotic agents
Adverse effects
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Metabolic Syndrome X
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Disease
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Affective Disorders, Psychotic
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Pathologic Processes
Risperidone
Aripiprazole
Quetiapine
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on October 19, 2014