Phase 4 N=224 Randomized Triple-blind Treatment

Treatment of Bipolar Mania in Older Adults

Bipolar Disorder · Mania

Bottom Line

View on ClinicalTrials.gov: NCT00254488 ↗

Enrolled (actual)

224

Serious AEs

20.5%

Results posted

Aug 2018

Primary outcome: Primary: Sedation Score — 0.5; 0.5; 0.6; 0.6 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lithium (LI) (Drug); Divalproex (DV) (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Weill Medical College of Cornell University
Primary completion: Aug 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Sedation Score	0.5; 0.5; 0.6; 0.6; 0.4; 0.5	—
PRIMARY Young Mania Rating Scale (YMRS) Scores	21.4; 19.7; 19.0; 16.3; 14.3; 15.2	—

Summary

This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.

Eligibility Criteria

Inclusion Criteria

Diagnosis of DSM-IV Bipolar Disorder, Type I: current manic, mixed, or hypomanic episodes

Exclusion Criteria

Rapid cycling bipolar disorder
History of substance abuse or dependence within last 3 months
Diagnosis of schizophrenia or other chronic psychotic conditions
Acute or unstable medical illness
Documented intolerance to Lithium, Depakote, Risperidone, or Lorazepam
Dementia
Inability to communicate in English

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00254488). 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.