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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

January 6, 2011
April 9, 2012
January 2011
January 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01272531 on ClinicalTrials.gov Archive Site
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Not Provided
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Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)
Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)
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.
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.
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
DNA from patients with bipolar disorder
Probability Sample
Inpatient and outpatients with bipolar affective disorder
Bipolar Affective Disorder
Drug: Mood stabilizer treatment
lithium or valproate
Other Names:
  • lithium carbonate
  • Eskalith
  • Lithobid
  • divalproex sodium
  • Depakote
  • Depakene
  • 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.
    Intervention: Drug: Mood stabilizer treatment
  • 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.
    Intervention: Drug: Mood stabilizer treatment
Oedegaard KJ, Alda M, Anand A, Andreassen OA, Balaraman Y, Berrettini WH, Bhattacharjee A, Brennand KJ, Burdick KE, Calabrese JR, Calkin CV, Claasen A, Coryell WH, Craig D, DeModena A, Frye M, Gage FH, Gao K, Garnham J, Gershon E, Jakobsen P, Leckband SG, McCarthy MJ, McInnis MG, Maihofer AX, Mertens J, Morken G, Nievergelt CM, Nurnberger J, Pham S, Schoeyen H, Shekhtman T, Shilling PD, Szelinger S, Tarwater B, Yao J, Zandi PP, Kelsoe JR. The Pharmacogenomics of Bipolar Disorder study (PGBD): identification of genes for lithium response in a prospective sample. BMC Psychiatry. 2016 May 5;16:129. doi: 10.1186/s12888-016-0732-x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
880
January 2016
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Norway
 
NCT01272531
NIH 1 U01 MH92758-01
Yes
Not Provided
Not Provided
John R. Kelsoe, MD, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: John R Kelsoe, M.D. University of California, San Diego
University of California, San Diego
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP