BC Mental Health & Addictions Research Institute
Vancouver, British Columbia, V5Z 4H4, Canada
NCT Number: NCT01739127
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.
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Notify Me12 year and older
All sexes
Observational
Vancouver, British Columbia, V5Z 4H4, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
Other names: ABILIFY
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
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).
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).
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).
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).
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.
University of British Columbia
Other
A Longitudinal Comparison of Aripiprazole vs. Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI
Acronym: CALM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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