Functional and Neurochemical Brain Changes Bipolar Depression

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University of Cincinnati

Status

Completed

Conditions

Depression, Bipolar

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00608296
BITREC - Project II

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

12 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

120 participants in 2 patient groups

1
Description:
Study subjects on lithium
2
Description:
study subjects on quetiapine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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