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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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