Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder
NCT01282281
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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.
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.
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| 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 |
| ||||||
| 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 | 13 | ||||||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| ||||||
| Sex/Gender |
| ||||||
| 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 |
| ||||||
| PRS Account | Sunnybrook Health Sciences Centre | ||||||
| Verification Date | January 2014 | ||||||