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

October 5, 2016 updated by: Caleb M. Adler, University of Cincinnati
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0559
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1
Manic Patients
Drug: lithium
600 mg - 1800 mg per day
OTHER: 2
Depressed Patients
Drug: Lithium
600 - 1800 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (ESTIMATE)

February 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 5, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adler #1
  • R01-0788043-01A1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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