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Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder (LAMBS/LADS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00608075
First Posted: February 6, 2008
Last Update Posted: October 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Caleb M. Adler, University of Cincinnati
  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: None (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 Caleb M. Adler, 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 ]

Estimated Enrollment: 260
Study Start Date: April 2007
Estimated Study Completion Date: July 2017
Primary Completion Date: July 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 23, 2008
First Posted: February 6, 2008
Last Update Posted: October 6, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs