Status:
COMPLETED
Genetic Predictors of Lithium Response in Bipolar Disorder
Lead Sponsor:
VA Office of Research and Development
Conditions:
Bipolar Disorder
Eligibility:
All Genders
21+ years
Brief Summary
The purpose of this study is to identify genetic predictors of lithium response in bipolar disorder.
Detailed Description
The long term focus of this research program has been identification of genes for bipolar disorder. The investigators have recently obtained evidence from several lines of investigation to support the...
Eligibility Criteria
Inclusion
- Are 18 years of age or older;
- Have a diagnosis of Bipolar Affective Disorder, I or II;
- Have no contraindications, allergies, or previous adverse events or treatment failures with lithium;
- Women who are not currently pregnant and are willing and able to use birth control;
- Are clinically appropriate to treat with lithium.
Exclusion
- DSM-IV Axis I Diagnosis: other primary comorbid axis I disorders such as: schizophrenia, schizoaffective disorder, delusional disorder;
- Alcohol or Substance Dependence: meets criteria for dependence within past 3 months;
- Unstable Medial Conditions: Life threatening or unstable medical condition that require active adjustment of medications by medical history; or
- Medical Conditions: concomitant medical condition that would preclude the use of lithium (i.e.: renal failure, head trauma with loss of consciousness, or clinically significant cardiac, renal, hepatic, neoplastic, or cardiovascular disease);
- Concomitant treatment with the following medications (during maintenance Phase): antipsychotics, antidepressants, antianxiety agent with the exception of benzodiazepines, to be used if needed for anxiety or insomnia, not to exceed 10 doses/week, or mood stabilizers with the exception of lithium; and
- Active suicidal or homicidal ideations as elicited in the interviews.
- Stable and doing well on a mood stabilizer other than lithium.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00252577
Start Date
October 1 2005
End Date
May 1 2016
Last Update
January 29 2020
Active Locations (1)
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1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161