Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder
Study Details
Study Description
Brief Summary
Background: Most psychotropic medications that are effective in the treatment of Bipolar Disorder (BD) are associated with endocrine-metabolic changes (EMCs). To date, there is no long-term study in BD that has examined specifically the association of inflammation with EMCs in BD. Specific aims: 1) to identify predictors of EMCs among adolescents and adults with BD who are being started on a medication ; 2) to compare change in EMCs in youth and adults treated for BD; 3) to measure change in EMCs associated with use of different medications for BD. Research Design: Participants: 30 adolescents (14-18 years old) with BD and 30 adults (19-65 years old) with BD. Measures: Blood levels of biomarkers that are associated with EMCs will be measured.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Individuals aged 14-18 and 19-65 with a diagnosis of BD
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Outcome Measures
Primary Outcome Measures
- Change in metabolic syndrome components [Screening, week 4/visit 2, week 12/visit 3, week 52/final visit]
i.e. weight glucose, lipids, blood pressure, etc.
Secondary Outcome Measures
- Cytokines, Chemokines, Insulin, Prolactin, Thyroid Hormone [Screening, week 4/visit 2, week 12/visit 3, week 52/final visit]
Cytokines include: pro-inflammatory markers such as c-reactive protein, interleukin-6, and tumor-necrosis factor alpha; anti-inflammatory cytokines include interleukin-4 Chemokines include: Leptin, Ghrelin and Adiponectin
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision of written informed consent
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Diagnosis of BD type I, II, or NOS as determined by DSM-IV diagnostic criteria (confirmed using SCID or K-SADS)
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Both females and males, age14 to 65 years
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Decision by physician and patient to initiate pharmacotherapy with a traditional mood stabilizer or atypical antipsychotic
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Able to understand and comply with requirements of the study
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Proficient in English.
Exclusion Criteria:
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A primary psychiatric disorder other than bipolar disorder I, II or NOS (comorbid Axis I or II disorders are permitted, as long as clinician judges that bipolar disorder is the primary condition)
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Initiation of an antipsychotic, mood stabilizer or other medication with known endocrine-metabolic effects within 4 weeks prior to baseline visit
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Patients who, in the investigators opinion, are unlikely to adhere to pharmacotherapy for at least 4 weeks after baseline visit
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Significant medical condition that would contraindicate the use of mood stabilizers or atypical antipsychotics
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Patients who are receiving pharmacological treatment for diabetes mellitus (DM), hyperlipidemia, or obesity
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Acute or chronic medical illness (e.g. urinary tract infection, bronchitis, rheumatoid arthritis) that, as judged by the investigator, would significantly alter inflammatory, metabolic, or endocrine indices
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Screening bloodwork that identifies any other clinically significant deviation from the reference range in clinical laboratory test results, as judged by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
Sponsors and Collaborators
- Dr. Ayal Schaffer
- Pfizer
Investigators
- Principal Investigator: Ayal Schaffer, MD, Sunnybrook Health Sciences Centre
- Principal Investigator: Benjamin Goldstein, MD, Sunnybrook Health Sciences Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WS688773