Functional and Neurochemical Brain Changes Bipolar Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Depression, Bipolar

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0559
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

You are being asked to take part in this research study because you have been diagnosed with bipolar disorder and are currently experiencing a depressive episode. Bipolar disorder is an illness characterized by recurrent mood swings including mania, (periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and clinical depression (periods of depressed mood, loss of interest in activities and disruption of sleep, appetite and energy). To participate in this study you must be at least 12 years old, and no older than 35.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Study subjects on lithium
2; study subjects on quetiapine

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 23, 2008
• First Submitted That Met QC Criteria: February 5, 2008
• First Posted (Estimate): February 6, 2008

Study Record Updates

• Last Update Posted (Estimate): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 22, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Bipolar Disorder
• Other Study ID Numbers: BITREC - Project II