Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)

June 4, 2020 updated by: John Kelsoe, University of California, San Diego
This is a prospective pharmacogenomics study of mood stabilizer response. The goal of this work is to identify genes associated with good response of patients with bipolar disorder to two commonly used mood stabilizing agents, lithium and valproate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All subjects meeting study inclusion criteria will be started on lithium. Those that fail lithium will be crossed over to valproate (VPA). Those that also fail VPA will be again crossed-over to a standardized treatment as usual (TAU) arm. Subjects who are eligible for the study must be at least 18 years of age and have been diagnosed or are thought to have bipolar I disorder with at least one episode of mood instability in the last 12 months. They must also be eligible to take lithium and, if female and of child bearing age, agree to use adequate birth control methods and to inform their doctor of their plans to become pregnant.

Study Type

Observational

Enrollment (Actual)

560

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

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2E2
        • Dalhousie University
  • Norway
      • Bergen, Norway, 5020
        • University of Bergen
  • United States
    • California
      • San Diego, California, United States, 92037
        • University of California San Diego
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-2700
        • University of Michigan
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-3309
        • University of Pennsylvania

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Inpatient and outpatients with bipolar affective disorder

Description

Inclusion Criteria:

  • Any phase of bipolar I disorder including, depressive, manic, hypomanic, mixed, or baseline/euthymic/not symptomatic;
  • Lithium naïve patients and inadequately past lithium treated patients will be required to have had at least one affective episode in the last 12 months meeting DSM-IV criteria. Current lithium treated patients (CLTPs) will be stable on lithium monotherapy and will be exempted from this criterion if they have had no mood episodes meeting DSM-IV criteria in the last 6 months;
  • Both outpatients and inpatients will be permitted to enroll into this study;
  • Able to give informed consent, in the judgment of the investigator;
  • Age greater than or equal to 18 years;
  • Women of child bearing potential agree to inform their doctor at the earliest possible time of their plans to conceive, and to use adequate contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence from intercourse), and to understand the risks of lithium to the fetus and infant. Depo Provera is acceptable if it is started 3 months prior to enrollment.

Exclusion Criteria:

  • Unwilling or unable to comply with study requirements;
  • Renal impairment (serum creatinine >1.5 mg/dL);
  • Thyroid stimulating hormone (TSH) over >20% above the upper normal limit (participants maintained on thyroid medication must be euthyroid for at least 3 months before Visit 1;
  • Other contraindication to lithium;
  • Currently in crisis such that inpatient hospitalization or other crisis management should take priority;
  • Subjects with alcohol/drug dependence who meet criteria for physical dependence requiring acute detoxification;
  • Pregnant or breastfeeding;
  • Women of child-bearing potential who aren't able to agree to the requirements specified above;
  • Those who have participated in a clinical trial of an investigational drug within the past 1 month;
  • Inability to agree to comply with the visit schedule or study procedures;
  • History of lithium toxicity, not due to mismanagement or overdose that required treatment;
  • Current unstable medical condition.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
lithium
All study subjects will be started on lithium and taken off other medications, such as antidepressants, antipsychotic or other mood stabilizers used to control their mood. They will be stabilized over a 3 month time period, observed for one month, the followed every 2 months for 2 years.
Drug: Mood stabilizer treatment
lithium or valproate
Other Names:
  • Lithobid
  • Depakote
  • Eskalith
  • lithium carbonate
  • Depakene
  • divalproex sodium
valproate
Subjects that do not achieve stabilization or relapse while on lithium monotherapy will be started on valproate (VPA), in an identically designed prospective trial of VPA.
Drug: Mood stabilizer treatment
lithium or valproate
Other Names:
  • Lithobid
  • Depakote
  • Eskalith
  • lithium carbonate
  • Depakene
  • divalproex sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to relapse
Time Frame: every 2 months for 2 years

Relapse definition:

  • meets criteria for mania and is considered "markedly ill" or worse; or
  • meets criteria for major depression with 4 week duration;
  • meets criteria for a mixed episode and is considered "markedly ill" or worse.
every 2 months for 2 years

Collaborators and Investigators

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

Sponsor

University of California, San Diego

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: John R Kelsoe, M.D., University of California, San Diego

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

Helpful Links

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 (ACTUAL)

April 1, 2011

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (ESTIMATE)

January 7, 2011

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIH 1 U01 MH92758-01
  • U01MH092758 (NIH)

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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