Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole | Participants receiving treatment with at least 10mg aripiprazole per day, as prescribed to them by their psychiatrists. |
| |
| Risperidone/Quetiapine | Participants receiving treatment with either risperidone or quetiapine, as prescribed to them by their psychiatrists. |
| |
| Control | Healthy participants who are not taking any antipsychotic medications. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal distribution of visceral fat versus subcutaneous fat | Change over time, and between groups, in amounts of visceral and subcutaneous fat as measured by automated segmentation of a magnetic resonance image (MRI). | Baseline (within 12 weeks of starting antipsychotic treatment), and 16 weeks later |
| Measure | Description | Time Frame |
|---|---|---|
| Fat content of the liver | Change over time, and between groups, in the amount of fat accumulation in the liver as measured by magnetic resonance spectroscopy (MRS). | Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later |
| Metabolic measures |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alasdair M Barr, Ph.D. | The University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Mental Health & Addictions Research Institute | Vancouver | British Columbia | V5Z 4H4 | Canada |
Not provided
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D018967 | Risperidone |
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| Risperidone/Quetiapine | Drug | To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study). |
|
|
Comparing change in the levels of hemoglobin, fasting lipid levels, adiponectin, leptin, insulin, and glucagon-like peptide 1 (GLP-1). |
| Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later |
| Glucose intolerance | Change over time, and between groups, in ability to tolerate a glucose challenge as measured by an oral glucose tolerance test (OGTT). | Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later |
| Potential genetic factors of antipsychotic-induced weight gain | 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. | Sample to be taken after 16 weeks of participation in the study |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |