Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)

Completed

Conditions studied: Bipolar Affective Disorder

In brief

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.

Key facts

Study ID

NCT01272531

Run by

University of California, San Diego

People needed

560

Starts

2011-04-01

Expected to finish

2016-04-01

Last updated by the study team

2020-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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