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Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01272531
Recruitment Status : Unknown
Verified April 2012 by University of California, San Diego.
Recruitment status was:  Recruiting
First Posted : January 7, 2011
Last Update Posted : April 10, 2012
Information provided by:
University of California, San Diego

Brief Summary:
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 or disease Intervention/treatment
Bipolar Affective Disorder Drug: Mood stabilizer 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.

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Study Type : Observational
Estimated Enrollment : 880 participants
Time Perspective: Prospective
Official Title: Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)
Study Start Date : January 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2016

Group/Cohort Intervention/treatment
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

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

Primary Outcome Measures :
  1. 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.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01272531

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Contact: Anna DeModena 858-642-3590
Contact: Susan G Leckband, R.Ph. 858-552-8585 ext 5337

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United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92037
Contact: Anna DeModena    858-642-3590   
Principal Investigator: John R. Kelsoe, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Ben Romanos    773-834-5128   
Principal Investigator: Elliot Gershon, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Carrie Fisher, RN    317-274-8844   
Principal Investigator: John Nurnberger, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Bruce H Tarwater, MSW, LISW    319-353-5684   
Principal Investigator: William Coryell, MD         
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Emma K Stokes, MHS    410-550-1652   
Principal Investigator: Peter Zandi, PhD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-2700
Contact: Gloria Harrington    877-864-3637   
Principal Investigator: Melvin McInnis, MD         
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Carla Conroy    216-844-2871   
Principal Investigator: Joe Calabrese, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-3309
Contact: Zachary Guy-Frank    215-746-6414   
Principal Investigator: Wade Berrettini, MD         
Canada, Nova Scotia
Dalhousie University Recruiting
Halifax, Nova Scotia, Canada, B3H 2E2
Contact: Julie Garnham, RN BN    (902) 473-7144   
Contact: Claire Slaney    (902) 473-5884   
Principal Investigator: Martin Alda, MD         
University of Bergen Recruiting
Bergen, Norway, 5020
Contact: Petter Jakobsen    (+47) 55 95 84 67    ,   
Principal Investigator: Ketil J Oedegaard, MD, PhD         
Sponsors and Collaborators
University of California, San Diego
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Principal Investigator: John R Kelsoe, M.D. University of California, San Diego

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: John R. Kelsoe, MD, University of California, San Diego Identifier: NCT01272531     History of Changes
Other Study ID Numbers: NIH 1 U01 MH92758-01
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012
Keywords provided by University of California, San Diego:
bipolar disorders
affective disorders
mood disorders
pharmacologic actions
psychotropic drugs
antimanic agents
antidepressant agents
lithium carbonate
divalproex sodium
Additional relevant MeSH terms:
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Bipolar Disorder
Mood Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
GABA Agents
Neurotransmitter Agents