Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01282281
Recruitment Status : Completed
First Posted : January 24, 2011
Last Update Posted : January 17, 2014
Information provided by (Responsible Party):
Dr. Ayal Schaffer, Sunnybrook Health Sciences Centre

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
Bipolar Disorder Youth Adults

Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder.
Study Start Date : January 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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

Primary Outcome Measures :
  1. Change in metabolic syndrome components [ Time Frame: Screening, week 4/visit 2, week 12/visit 3, week 52/final visit ]
    i.e. weight glucose, lipids, blood pressure, etc.

Secondary Outcome Measures :
  1. Cytokines, Chemokines, Insulin, Prolactin, Thyroid Hormone [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01282281

Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Dr. Ayal Schaffer
Principal Investigator: Ayal Schaffer, MD Sunnybrook Health Sciences Centre
Principal Investigator: Benjamin Goldstein, MD Sunnybrook Health Sciences Centre

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 Identifier: NCT01282281     History of Changes
Other Study ID Numbers: WS688773
First Posted: January 24, 2011    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: January 2014

Keywords provided by Dr. Ayal Schaffer, Sunnybrook Health Sciences Centre:
Bipolar Disorder
Endocrine-metabolic changes

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders