Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder

NCT ID: NCT01282281

Last Updated: 2014-01-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-09-30

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.

Conditions

Bipolar Disorder; Youth; Adults

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Individuals aged 14-18 and 19-65 with a diagnosis of BD

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Dr. Ayal Schaffer

OTHER

Sponsor Role: lead

Responsible Party

Dr. Ayal Schaffer

Head, Mood & Anxiety Disorders Program; Deputy Psychiatrist-in-Chief, Department of Psychiatry; Associate Professor, University of Toronto

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ayal Schaffer, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Benjamin Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

WS688773

Identifier Type: -

Identifier Source: org_study_id