Treatment of Bipolar Mania in Older Adults

Phase 4

Completed

• Conditions: Mania; Bipolar Disorder
• Interventions: Drug: Lithium (LI); Drug: Divalproex (DV)

• Registration Number: NCT00254488
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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

Detailed Description

This is the first controlled acute treatment study of bipolar disorder in adults 60 years or older with current DSM-IV manic, mixed, or hypomanic episodes. The number of older adults with severe and disabling bipolar disorder is increasing, and information to guide the management of the treatment of the disease is lacking in this population. Guidelines for treatment of younger people with bipolar disorder cannot be used for older people, and there are no safety and efficacy data upon which to base initial treatment decisions for older patients with bipolar mania. Mood stabilizers (lithium and divalproex) are the first-line treatment for bipolar disorder. However, in aged patients physiological changes and comorbid diseases may increase vulnerability to side effects and limit the benefits of the medications.

This double-blind study will compare the benefits and side-effects of 9 weeks of treatment with lithium and divalproex in people with bipolar mania. Participants, who may be treated during inpatient hospitalization or as outpatients, will be randomly assigned to receive either lithium or divalproex. During the first 3 weeks of treatment careful titration of lithium and divalproex will be done to reach dose ranges. All other psychotropic medications will be discontinued. Behavioral interventions and/or lorazepam may be added, if necessary. After the first 3 weeks, if symptoms do not improve, risperidone will be added to be taken everyday with the study medication.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-14
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-16
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2018-07-19
• Results First Submitted QC: 2018-07-19
• Status Verified: 2018-08
• Results First Posted: 2018-08-14
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lithium (LI)	Lithium (LI)	Participants will receive 9 weeks of treatment with lithium
Divalproex (DV)	Divalproex (DV)	Participants will receive 9 weeks of treatment with divalproex

Primary Outcome Measures

Name	Time	Method
Sedation Score	Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9	The Sedation Item score of the UKU (Norwegian for Committee of Clinical Investigations) Side Effect Rating Scale. A higher value indicates greater severity. Range is 0-3 (not present, mild, moderate, or severe).
Young Mania Rating Scale (YMRS) Scores	Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9	The Young Mania Rating Scale is an eleven item interviewer-rated instrument. Four items are scored 0-8, the others 0-4. The total score therefore ranges from 0-60, with higher values reflecting greater severity.

Trial Locations

Locations (8)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

Weill Cornell Medical College; 🇺🇸 White Plains, New York, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Precise Research Centers; 🇺🇸 Flowood, Mississippi, United States

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada