N/A
Completed N=130
Genetic Predictors of Lithium Response in Bipolar Disorder
Source: ClinicalTrials.gov NCT00252577 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Time to Relapse — 24.6 months
Summary
The purpose of this study is to identify genetic predictors of lithium response in bipolar disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Relapse |
24.6 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00252577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.