Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder
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Purpose
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 |
|---|
|
Bipolar Disorder Youth Adults |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder. |
- Change in metabolic syndrome components [ Time Frame: Screening, week 4/visit 2, week 12/visit 3, week 52/final visit ] [ Designated as safety issue: No ]i.e. weight glucose, lipids, blood pressure, etc.
- Cytokines, Chemokines, Insulin, Prolactin, Thyroid Hormone [ Time Frame: Screening, week 4/visit 2, week 12/visit 3, week 52/final visit ] [ Designated as safety issue: No ]
- 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
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Individuals aged 14-18 and 19-65 with a diagnosis of BD |
Eligibility| Ages Eligible for Study: | 14 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Thirty adolescent participants with BD (type I, II, or not otherwise specified), and 30 adult participants with BD will be enrolled. Participants with BD will be recruited from the Youth and Adult Mood Disorder Clinics. Psychiatry Division staff will identify patients who meet the study criteria during weekly treatment team meetings. New referrals will also be screened to identify potential participants.
Inclusion Criteria:
- Provision of written informed consent
- Diagnosis of BD type I, II, or NOS as determined by DSM-IV diagnostic criteria (confirmed using SCID or K-SADS)
- Both females and males, age14 to 65 years
- Decision by physician and patient to initiate pharmacotherapy with a traditional mood stabilizer or atypical antipsychotic
- Able to understand and comply with requirements of the study
- Proficient in English.
Exclusion Criteria:
- 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)
- Initiation of an antipsychotic, mood stabilizer or other medication with known endocrine-metabolic effects within 4 weeks prior to baseline visit
- Patients who, in the investigators opinion, are unlikely to adhere to pharmacotherapy for at least 4 weeks after baseline visit
- Significant medical condition that would contraindicate the use of mood stabilizers or atypical antipsychotics
- Patients who are receiving pharmacological treatment for diabetes mellitus (DM), hyperlipidemia, or obesity
- 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
- 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| Contact: Melody Yuen, B.A. | 416-480-6100 ext 5283 | melody.yuen@sunnybrook.ca |
| Contact: Catherine Reis, B.A. | 416-480-6100 ext 4092 | catherine.reis@sunnybrook.ca |
| Canada, Ontario | |
| Sunnybrook Health Sciences Centre | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Melody Yuen, B.A. 416-480-6100 ext 5283 melody.yuen@sunnybrook.ca | |
| Contact: Catherine Reis, B.A. 416-480-6100 ext 4092 catherine.reis@sunnybrook.ca | |
| Principal Investigator: Ayal Schaffer, MD | |
| Principal Investigator: Benjamin Goldstein, MD | |
| Sub-Investigator: Gregory Chandler, MD | |
| Sub-Investigator: Anthony Levitt, MD | |
| Sub-Investigator: Krista Lanctot, MD | |
| Principal Investigator: | Ayal Schaffer, MD | Sunnybrook Health Sciences Centre |
| Principal Investigator: | Benjamin Goldstein, MD | Sunnybrook Health Sciences Centre |
More Information
No publications provided
| Responsible Party: | Dr. Ayal Schaffer, Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT01282281 History of Changes |
| Other Study ID Numbers: | WS688773 |
| Study First Received: | January 21, 2011 |
| Last Updated: | July 25, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Sunnybrook Health Sciences Centre:
|
Bipolar Disorder Youth Adults Endocrine-metabolic changes |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 17, 2013