Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder

NCT01282281

Last updated date
Study Location
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder, Youth, Adults
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
14-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Bipolar Disorder, Youth, AdultsProspective Metabolic Monitoring of Youth and Adults With Bipolar Disorder
NCT01282281
  1. Toronto, Ontario
ALL GENDERS
14 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder
Official Title Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Bipolar Disorder
  • Youth
  • Adults
Intervention Not Provided
Study Groups/Cohorts Individuals aged 14-18 and 19-65 with a diagnosis of BD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 16, 2014)
13
Original Estimated Enrollment
 (submitted: January 21, 2011)
60
Actual Study Completion Date September 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:All
Ages 14 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01282281
Other Study ID Numbers WS688773
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Ayal Schaffer, Sunnybrook Health Sciences Centre
Study Sponsor Dr. Ayal Schaffer
Collaborators Pfizer
Investigators
Principal Investigator:Ayal Schaffer, MDSunnybrook Health Sciences Centre
Principal Investigator:Benjamin Goldstein, MDSunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date January 2014