Overview

Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)

Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, San Diego
Collaborator:
National Institute of Mental Health (NIMH)
Treatments:
Lithium Carbonate
Valproic Acid
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.