Functional and Neurochemical Brain Changes Bipolar Depression
NCT ID: NCT00608296
Last Updated: 2014-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
120 participants
OBSERVATIONAL
2008-01-31
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Study subjects on lithium
No interventions assigned to this group
2
study subjects on quetiapine
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
12 Years
35 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
University of Cincinnati
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Caleb M. Adler
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Caleb M Adler, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Cincinnati
Cincinnati, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BITREC - Project II
Identifier Type: -
Identifier Source: org_study_id