Functional and Neurochemical Brain Changes Bipolar Depression

Depression, Bipolar Clinical Trial

Official title:

Functional and Neurochemical Brain Changes Following Successful Treatment of Early Course Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608296
• Other study ID #: BITREC - Project II
• 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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depressive Disorder

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,