Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Mania

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Caleb M. Adler, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00608075
First received: January 23, 2008
Last updated: December 9, 2013
Last verified: December 2013
  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 I Disorder
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:


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: 260
Study Start Date: April 2007
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608075

Locations
United States, Ohio
University of Cincinnati
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, Associate Professor, 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: December 9, 2013
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 August 26, 2014