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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00608296
Other study ID # BITREC - Project II
Secondary ID
Status Completed
Phase N/A
First received January 23, 2008
Last updated December 22, 2014
Start date January 2008
Est. completion date July 2013

Study information

Verified date December 2014
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving quetiapine or lithium, in order to better understand who benefits from treatment and why they respond to medications.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 35 Years
Eligibility Inclusion Criteria - Depressed bipolar patients (N=100; 15-20 patients/year):

1. Patients will meet DSM-IV criteria for type I bipolar disorder, depressed, as determined by structured interview and best-estimate diagnostic procedures.138

2. Patient has experienced a maximum of three documented affective episodes.

3. Patient has been off medications for one week prior to study enrollment.

4. Patient has a Hamilton Depression Rating Scale (HDRS) total score =20

5. Patient is between the ages of 12 and 35 years.

Exclusion criteria: All subjects will be excluded from participation for the following reasons:

1. Any chemical use disorder within 3 months.

2. Any history of significant suicidality that would place the patient at risk to participate in this protocol.

3. Current score =3 on item 3 of the HDRS-17 (Suicide Item)

4. Any medical or neurological disorder that could influence fMRI results.

5. A history of mental retardation or an estimated IQ total score <85.

6. An MRI scan is contraindicated in the subject for any reason.

7. The patient lives >100 miles from the University of Cincinnati or cannot attend follow-up visits.

8. Meets DSM-IV criteria for a bipolar mixed episode

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States University of Cincinnati Cincinnati Ohio

Sponsors (2)

Lead Sponsor Collaborator
University of Cincinnati National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

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