Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bipolar I Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Manic Patients

Group Type OTHER

lithium

Intervention Type DRUG

600 mg - 1800 mg per day

2

Depressed Patients

Group Type OTHER

Lithium

Intervention Type DRUG

600 - 1800 mg

Interventions

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lithium

600 mg - 1800 mg per day

Intervention Type DRUG

Lithium

600 - 1800 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.

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

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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes