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Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder

Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00608075
Acronym
LAMBS/LADS
Enrollment
260
Registered
2008-02-06
Start date
2007-04-30
Completion date
2017-07-31
Last updated
2016-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar I Disorder

Brief summary

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.

Interventions

DRUGlithium

600 mg - 1800 mg per day

DRUGLithium

600 - 1800 mg

Sponsors

University of Cincinnati
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving lithium.8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026