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OpenTrials
Completed

NCT Number: NCT00608296

Functional and Neurochemical Brain Changes 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.

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Key information

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267-0559, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Depressed bipolar patients (N=100; 15-20 patients/year):

  • 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.

Exclusion criteria

All subjects will be excluded from participation for the following reasons:

  • 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 and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Feb 6, 2008
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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