Genetic Predictors of Lithium Response in Bipolar Disorder

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to identify genetic predictors of lithium response in bipolar disorder.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Lithium Carbonate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.