Functional and Neurochemical Brain Changes Bipolar Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Caleb M. Adler, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00608296
First received: January 23, 2008
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition
Depression, Bipolar

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional and Neurochemical Brain Changes Following Successful Treatment of Early Course Bipolar Depression

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Estimated Enrollment: 120
Study Start Date: January 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Study subjects on lithium
2
study subjects on quetiapine

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608296

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Caleb M Adler, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Caleb M. Adler, Associate Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00608296     History of Changes
Other Study ID Numbers: BITREC - Project II
Study First Received: January 23, 2008
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 26, 2014