Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282281
• Other study ID #: WS688773
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: January 16, 2014
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Provision of written informed consent

2. Diagnosis of BD type I, II, or NOS as determined by DSM-IV diagnostic criteria (confirmed using SCID or K-SADS)

3. Both females and males, age14 to 65 years

4. Decision by physician and patient to initiate pharmacotherapy with a traditional mood stabilizer or atypical antipsychotic

5. Able to understand and comply with requirements of the study

6. Proficient in English.

Exclusion Criteria:

1. 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)

2. Initiation of an antipsychotic, mood stabilizer or other medication with known endocrine-metabolic effects within 4 weeks prior to baseline visit

3. Patients who, in the investigators opinion, are unlikely to adhere to pharmacotherapy for at least 4 weeks after baseline visit

4. Significant medical condition that would contraindicate the use of mood stabilizers or atypical antipsychotics

5. Patients who are receiving pharmacological treatment for diabetes mellitus (DM), hyperlipidemia, or obesity

6. 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

7. Screening bloodwork that identifies any other clinically significant deviation from the reference range in clinical laboratory test results, as judged by the investigator.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adults
• Bipolar Disorder
• Youth

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Ayal Schaffer	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in metabolic syndrome components	i.e. weight glucose, lipids, blood pressure, etc.	Screening, week 4/visit 2, week 12/visit 3, week 52/final visit	No
Secondary	Cytokines, Chemokines, Insulin, Prolactin, Thyroid Hormone	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	Screening, week 4/visit 2, week 12/visit 3, week 52/final visit	No