Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)
Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Affective Disorder
Intervention: Mood stabilizer treatment (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of California, San Diego Official(s) and/or principal investigator(s): John R Kelsoe, M.D., Principal Investigator, Affiliation: University of California, San Diego
Overall contact: Anna DeModena, Phone: 858-642-3590, Email: ademodena@ucsd.edu
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.
Clinical Details
Official title: Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)
Study design: Time Perspective: Prospective
Primary outcome: Time to relapse
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Anna DeModena, Phone: 858-642-3590, Email: ademodena@ucsd.edu
University of Bergen, Bergen 5020, Norway; Recruiting Petter Jakobsen, Phone: (+47) 55 95 84 67, Email: , petter.jakobsen@helse-bergen.no Ketil J Oedegaard, MD, PhD, Principal Investigator
University of California San Diego, San Diego, California 92037, United States; Recruiting Anna DeModena, Phone: 858-642-3590, Email: ademodena@ucsd.edu John R. Kelsoe, MD, Principal Investigator
University of Chicago, Chicago, Illinois 60637, United States; Recruiting Ben Romanos, Phone: 773-834-5128, Email: bromanos@yoda.bsd.uchicago.edu Elliot Gershon, MD, Principal Investigator
Indiana University, Indianapolis, Indiana 46202, United States; Recruiting Carrie Fisher, RN, Phone: 317-274-8844, Email: cfisher2@iupui.edu John Nurnberger, MD, Principal Investigator
University of Iowa, Iowa City, Iowa 52242, United States; Recruiting Bruce H Tarwater, MSW, LISW, Phone: 319-353-5684, Email: bruce-tarwater@uiowa.edu William Coryell, MD, Principal Investigator
Johns Hopkins Hospital, Baltimore, Maryland 21287, United States; Recruiting Emma K Stokes, MHS, Phone: 410-550-1652, Email: estokes9@jhmi.edu Peter Zandi, PhD, Principal Investigator
University of Michigan, Ann Arbor, Michigan 48109-2700, United States; Recruiting Gloria Harrington, Phone: 877-864-3637, Email: BPResearch@umich.edu Melvin McInnis, MD, Principal Investigator
Dalhousie University, Halifax, Nova Scotia B3H 2E2, Canada; Recruiting Julie Garnham, RN BN, Phone: (902) 473-7144, Email: jgarnham@dal.ca Claire Slaney, Phone: (902) 473-5884, Email: Claire.Slaney@cdha.nshealth.ca Martin Alda, MD, Principal Investigator
University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States; Recruiting Carla Conroy, Phone: 216-844-2871, Email: Carla.Conroy@uhhospitals.org Joe Calabrese, MD, Principal Investigator
University of Pennsylvania, Philadelphia, Pennsylvania 19104-3309, United States; Recruiting Zachary Guy-Frank, Phone: 215-746-6414, Email: guyfrank@mail.med.upenn.edu Wade Berrettini, MD, Principal Investigator
Additional Information
PGBD website
Starting date: January 2011
Last updated: April 9, 2012
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