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Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Mania

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Cincinnati.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00608075
First received: January 23, 2008
Last updated: February 21, 2011
Last verified: February 2011
History of Changes
  Purpose

The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving lithium, an FDA-approved treatment for bipolar mania, in order to better understand who benefits from treatment and why they respond to medications. Studying this may help improve treatment and outcome in patients with bipolar disorder.


Condition Intervention Phase
Bipolar
 Drug: lithium
Drug: Lithium
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving lithium. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2007
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Manic Patients
 Drug: lithium
600 mg - 1800 mg per day
2
Depressed Patients
 Drug: Lithium
600 - 1800 mg

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria- bipolar patients (Manic=, depressed=60; 30 patients/year):

  1. The patient meets DSM-IV criteria for type I bipolar disorder, manic or mixed, or depressed.
  2. The patient has an index Young Mania Rating Scale (YMRS)total score >15 or Montgomery Asberg Rating Scale (MADRS) total score >20.
  3. The patient is between 15 and 55 years old.

Inclusion Criteria- Healthy subjects (N=40):

  1. Healthy subjects will be between the ages of 15 and 55 years.
  2. Healthy subjects will have no history of any Axis I psychiatric disorder.
  3. Healthy subjects will have no first-degree relatives with affective or psychotic disorders.

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

  1. Any medical or neurological disorder that could influence fMRI and MRS results.
  2. A history of mental retardation or an estimated IQ total score <85.
  3. An MRI scan is contraindicated in the subject for any reason, including psychological impediments to being inside the MR scanner.
  4. The patient cannot attend follow-up visits.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608075

Contacts
Contact: Emily Rummelhoff 513-558-4295 emily.rummelhoff@uc.edu

Locations
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Caleb M Adler, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Caleb M. Adler, MD, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00608075     History of Changes
Other Study ID Numbers: Adler #1, R01-0788043-01A1
Study First Received: January 23, 2008
Last Updated: February 21, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lithium
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013