Status:
COMPLETED
Bipolar Disorder Research Study for Ages 12 and Older
Lead Sponsor:
Kupfer, David J., M.D.
Collaborating Sponsors:
Bristol-Myers Squibb
Abbott
Conditions:
Bipolar Disorder
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
The Bipolar Disorder Center for Pennsylvanians aims to reduce significant differences in treatment results among Pennsylvanians with bipolar disorder, especially among youth, the elderly, rural reside...
Detailed Description
Bipolar disorder is one of the world's most disabling conditions, robbing sufferers of years of healthy functioning. The presence of bipolar disorder is not limited to any nation, race, age, gender, o...
Eligibility Criteria
Inclusion
- Age greater than or equal to 12 years.
- Able to give basic informed consent.
- Meets DSM-IV Criteria for Bipolar I, Bipolar II (if in the investigator's judgment long term treatment with a mood stabilizer is indicated), Bipolar NOS, or Schizoaffective Bipolar subtype.
- Because many adolescents have shorter periods of mania or hypomania than those required by the DSM-IV (at least 4 days for hypomania and 7 days for mania) adolescents are included who have a current episode of MDD and a history of episodes mania/hypomania that lasted for at least 2 days.
Exclusion
- Unwilling or unable to comply with study requirements (e.g., complete study forms, attend scheduled evaluations).
- Not competent to provide informed consent in the opinion of the investigator.
- Mental retardation (IQ less than 70). Subjects suspected of mental retardation (e.g., chronic academic failure, multiple developmental delays) are evaluated using the Verbal Subtest of the Wechsler Intelligence test.
- Presence of schizophrenia, schizoaffective pervasive developmental disorder, current substance or alcohol dependence, and organic mental disorder. Substance dependence in early remission is not an exclusion criterion.
- Unstable medical illness or other medical contraindication to treatment with mood stabilizers, antidepressants or antipsychotic medications.
- Women who are planning to become pregnant, pregnant or breast-feeding.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00211263
Start Date
November 1 2003
End Date
February 1 2007
Last Update
April 8 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
DuBois Regional Medical Center
DuBois, Pennsylvania, United States, 15801
2
Thomas Jefferson University University
Philadelphia, Pennsylvania, United States, 19107
3
University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213