Functional and Neurochemical Brain Changes Bipolar Depression

NCT00608296 | Completed

• 1 other identifier: BITREC - Project II
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Bipolar

Study Arms (2)

1

Study subjects on lithium

2

study subjects on quetiapine

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Patients will meet DSM-IV criteria for type I bipolar disorder, depressed, as determined by structured interview and best-estimate diagnostic procedures.138
• Patient has experienced a maximum of three documented affective episodes.
• Patient has been off medications for one week prior to study enrollment.
• Patient has a Hamilton Depression Rating Scale (HDRS) total score ≥20
• Patient is between the ages of 12 and 35 years.

You may not qualify if:

• Any chemical use disorder within 3 months.
• Any history of significant suicidality that would place the patient at risk to participate in this protocol.
• Current score ≥3 on item 3 of the HDRS-17 (Suicide Item)
• Any medical or neurological disorder that could influence fMRI results.
• A history of mental retardation or an estimated IQ total score \<85.
• An MRI scan is contraindicated in the subject for any reason.
• The patient lives \>100 miles from the University of Cincinnati or cannot attend follow-up visits.
• Meets DSM-IV criteria for a bipolar mixed episode

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267-0559, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Caleb M Adler, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

US (1)