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Functional and Neurochemical Brain Changes Bipolar Depression

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00608296
Enrollment
120
Registered
2008-02-06
Start date
2008-01-31
Completion date
2013-07-31
Last updated
2014-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Bipolar

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.

Interventions

None listed

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Cincinnati
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026