Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by University of California, San Diego.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01272531
First received: January 6, 2011
Last updated: April 9, 2012
Last verified: April 2012
  Purpose
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.

Condition Intervention Phase
Bipolar Affective Disorder
Drug: Mood stabilizer treatment
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Time to relapse [ Time Frame: every 2 months for 2 years ] [ Designated as safety issue: No ]

    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.


Biospecimen Retention:   Samples With DNA
DNA from patients with bipolar disorder

Estimated Enrollment: 880
Study Start Date: January 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • lithium carbonate
  • Eskalith
  • Lithobid
  • divalproex sodium
  • Depakote
  • Depakene
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:
  • lithium carbonate
  • Eskalith
  • Lithobid
  • divalproex sodium
  • Depakote
  • Depakene

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Inpatient and outpatients with bipolar affective disorder
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272531

Locations
United States, California
University of California San Diego
San Diego, California, United States, 92037
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-2700
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-3309
Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 2E2
Norway
University of Bergen
Bergen, Norway, 5020
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: John R Kelsoe, M.D. University of California, San Diego
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John R. Kelsoe, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01272531     History of Changes
Other Study ID Numbers: NIH 1 U01 MH92758-01 
Study First Received: January 6, 2011
Last Updated: April 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
pharmacogenetics
bipolar disorders
affective disorders
mood disorders
pharmacologic actions
psychotropic drugs
antimanic agents
antidepressant agents
lithium
lithium carbonate
Lithobid
Eskalith
divalproex
divalproex sodium
Depakote
valproate

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Mood Disorders
Genetic Diseases, X-Linked
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Genetic Diseases, Inborn
Lithium Carbonate
Valproic Acid
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticonvulsants
GABA Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on December 07, 2016