Treatment of Bipolar Mania in Older Adults

Bipolar Disorder Clinical Trial

— GERI-BD  

Official title:

Acute Pharmacotherapy of Late-Life Mania (GERI-BD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254488
• Other study ID #: U01MH068847
• Secondary ID: U01MH068847
• Status: Completed
• Phase: Phase 4
• Start date: November 2005
• Est. completion date: August 2011

Study information

• Verified date: August 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Mania

Intervention

Drug:
• Lithium (LI)
The starting LI dose will be 150 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma LI level ranges between 0.40 and 0.99 mEq/L (target 0.80 to 0.99 mEq/L).
• Divalproex (DV)
Dosage of DV will be 250 mg in the morning and evening. The dose of medication will be adjusted to achieve plasma DV level ranges between 40 and 99 mcg/mL (target 80 to 99 mcg/ml).

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Precise Research Centers	Flowood	Mississippi
United States	Baylor College of Medicine	Houston	Texas
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Weill Cornell Medical College	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (5)

Al Jurdi RK, Schulberg HC, Greenberg RL, Kunik ME, Gildengers A, Sajatovic M, Mulsant BH, Young RC; GERI-BD Study Group. Characteristics associated with inpatient versus outpatient status in older adults with bipolar disorder. J Geriatr Psychiatry Neurol. — View Citation

Beyer JL, Greenberg RL, Marino P, Bruce ML, Al Jurdi RK, Sajatovic M, Gyulai L, Mulsant BH, Gildengers A, Young RC. Social support in late life mania: GERI-BD. Int J Geriatr Psychiatry. 2014 Oct;29(10):1028-32. doi: 10.1002/gps.4093. Epub 2014 Mar 24. — View Citation

Gildengers AG, Mulsant BH, Al Jurdi RK, Beyer JL, Greenberg RL, Gyulai L, Moberg PJ, Sajatovic M, ten Have T, Young RC; GERI-BD Study Group. The relationship of bipolar disorder lifetime duration and vascular burden to cognition in older adults. Bipolar D — View Citation

Sajatovic M, Al Jurdi R, Gildengers A, Greenberg RL, Tenhave T, Bruce ML, Mulsant B, Young RC. Depression symptom ratings in geriatric patients with bipolar mania. Int J Geriatr Psychiatry. 2011 Nov;26(11):1201-8. doi: 10.1002/gps.2664. Epub 2011 Mar 1. — View Citation

Young RC, Schulberg HC, Gildengers AG, Sajatovic M, Mulsant BH, Gyulai L, Beyer J, Marangell L, Kunik M, Ten Have T, Bruce ML, Gur R, Marino P, Evans JD, Reynolds CF 3rd, Alexopoulos GS. Conceptual and methodological issues in designing a randomized, cont — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation Score	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).	Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9
Primary	Young Mania Rating Scale (YMRS) Scores	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.	Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9