NCT00211263

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 residents, and African Americans who are less likely to receive adequate treatment, less likely to remain in treatment once identified, and less likely to have positive results if they remain in treatment. Half of the subjects receive either Guideline Intervention (GI) or Enhanced Clinical Intervention (ECI). ECI is a combination of information and support, such as education about bipolar disorder, the medications used to treat it, information about sleep practices and habits that affect quality of sleep, review of symptoms, medication side effects, and coping with side effects. It is predicted that Enhanced Clinical Intervention will be more effective in reducing the differences in results between those most at risk compared to mid-life Caucasians. The treatment study occurs at three sites across Pennsylvania and has emphasized the recruitment of African Americans, youth (ages 12 through 18), and adults over age 65.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

April 8, 2015

Status Verified

June 1, 2005

First QC Date

September 13, 2005

Last Update Submit

April 7, 2015

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Key outcomes among all enrollments are ascertained every two months and continue throughout the 48-month period of the study. Outcomes include symptom and psychosocial factors, treatment adherence, disease severity, and resource utilization.

Secondary Outcomes (1)

  • Blood samples are drawn for pharmacotherapy exposure studies for each subject 11 times during the course of the study.

Study Arms (2)

Enhanced Clinical Intervention

EXPERIMENTAL
Behavioral: Enhanced Clinical InterventionDrug: mood stabilizer

Clinical Intervention

ACTIVE COMPARATOR
Drug: mood stabilizer

Interventions

Enhanced Clinical InterventionBEHAVIORAL
Enhanced Clinical Intervention
mood stabilizerDRUG
Clinical InterventionEnhanced Clinical Intervention

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

DuBois Regional Medical Center

DuBois, Pennsylvania, 15801, United States

Location

Thomas Jefferson University University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Fagiolini A, Frank E, Turkin S, Houck PR, Soreca I, Kupfer DJ. Metabolic syndrome in patients with bipolar disorder. J Clin Psychiatry. 2008 Apr;69(4):678-9. doi: 10.4088/jcp.v69n0423c. No abstract available.

    PMID: 18507490DERIVED

Related Links

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • David J Kupfer, MD

    University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2003

Study Completion

February 1, 2007

Last Updated

April 8, 2015

Record last verified: 2005-06

Locations

US(3)