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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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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