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OpenTrials
Completed

NCT Number: NCT01282281

Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder

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.

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Key information

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dr. Ayal Schaffer

Other

Collaborators

  • Pfizer

Registry information

Official study title

Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 24, 2011
Registry last updated
Jan 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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