Functional and Neurochemical Brain Changes Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00608296
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : December 23, 2014
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Caleb M. Adler, University of Cincinnati

Brief 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.

Condition or disease
Depression, Bipolar

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional and Neurochemical Brain Changes Following Successful Treatment of Early Course Bipolar Depression
Study Start Date : January 2008
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Study subjects on lithium
study subjects on quetiapine

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00608296

United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
University of Cincinnati
National Institutes of Health (NIH)
Principal Investigator: Caleb M Adler, MD University of Cincinnati

Responsible Party: Caleb M. Adler, Associate Professor, University of Cincinnati Identifier: NCT00608296     History of Changes
Other Study ID Numbers: BITREC - Project II
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders