Bipolar Disorder, Metabolic Syndrome X, Psychotic Disorders
Conditions
Keywords
Antipsychotic agents, Adverse effects, Magnetic Resonance Imaging
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.
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.
Interventions
DRUGAripiprazole
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
DRUGRisperidone/Quetiapine
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
Sponsors
Bristol-Myers Squibb
University of British Columbia
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal distribution of visceral fat versus subcutaneous fat | 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
| Measure | Time frame | Description |
|---|---|---|
| Glucose intolerance | 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). |
| Fat content of the liver | 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). |
| Metabolic measures | 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). |
| Potential genetic factors of antipsychotic-induced weight gain | 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. |
Countries
Canada
Outcome results
None listed