Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)

Bipolar Affective Disorder Clinical Trial

Official title:

Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272531
• Other study ID #: NIH 1 U01 MH92758-01
• Secondary ID: U01MH092758
• Status: Completed
• Start date: April 2011
• Est. completion date: April 2016

Study information

• Verified date: June 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Affective Disorder
• Bipolar Disorder
• Disease
• Mood Disorders

Intervention

Drug:
• Mood stabilizer treatment
lithium or valproate

Locations

Country	Name	City	State
Canada	Dalhousie University	Halifax	Nova Scotia
Norway	University of Bergen	Bergen
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Chicago	Chicago	Illinois
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of California San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  Canada,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to relapse	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

External Links

•   PGBD website