Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Dr. Ayal Schaffer, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01282281
First received: January 21, 2011
Last updated: January 16, 2014
Last verified: January 2014
  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.

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 13
Study Start Date: January 2011
Study Completion Date: September 2013
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
Study Population

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282281

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: Dr. Ayal Schaffer, Head, Mood & Anxiety Disorders Program; Deputy Psychiatrist-in-Chief, Department of Psychiatry; Associate Professor, University of Toronto, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01282281     History of Changes
Other Study ID Numbers: WS688773
Study First Received: January 21, 2011
Last Updated: January 16, 2014
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
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014