Treatment of Bipolar Mania in Older Adults - Full Text View

Purpose

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

Condition	Intervention	Phase
Bipolar Disorder Mania	Drug: Lithium (LI) Drug: Divalproex (DV)	Phase IV

MedlinePlus related topics:

Bipolar Disorder

ChemIDplus related topics:

Divalproex sodium Valproate Sodium Valproic acid Lithium carbonate Lithium citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Acute Pharmacotherapy of Late-Life Mania (GERI-BD)

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Side effects, such as sedation, tremor, GI complaints, and weight gain [ Time Frame: Measured over 9 weeks of treatment ] [ Designated as safety issue: No ]
Efficacy measures such as manic symptom scores, life activities functioning, and quality of life [ Time Frame: Measured at baseline and Week 9 ] [ Designated as safety issue: No ]

Estimated Enrollment:	258
Study Start Date:	November 2005
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive 9 weeks of treatment with lithium	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).
2: Experimental Participants will receive 9 weeks of treatment with divalproex	Drug: 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).

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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254488

Contacts


Contact: Laurie Davan	914-682-9100 ext 2570	lad9011@med.cornell.edu

Locations


United States, Mississippi
	Precise Research Centers	Recruiting
	Flowood, Mississippi, United States, 39232
	Contact: Taheera Hoskins 601-420-5810 thoskins@precise-research.com
	Principal Investigator: Joseph Kwentus, MD

United States, New York
	Weill Cornell Medical College	Recruiting
	White Plains, New York, United States, 10605
	Contact: Laurie Davan 914-682-9100 ext 2570 lad9011@med.cornell.edu
	Principal Investigator: Robert Young, MD
	Sub-Investigator: Herbert Schulberg, PhD

United States, North Carolina
	Duke University Medical Center	Recruiting
	Durham, North Carolina, United States, 27710
	Contact: Mike Mani 919-681-8362 mani0002@mc.duke.edu
	Principal Investigator: John Beyer, MD

United States, Ohio
	University Hospitals Case Medical Center	Recruiting
	Cleveland, Ohio, United States, 44106
	Contact: Kristin Cassidy 216-844-2834 Kristin.Cassidy@uhhospitals.org
	Principal Investigator: Martha Sajatovic, MD

United States, Pennsylvania
	University of Pennsylvania	Recruiting
	Philadelphia, Pennsylvania, United States, 19104
	Contact: Marna Barrett 215-746-6414 msb@mail.med.upenn.edu
	Principal Investigator: Laszlo Gyulai, MD
	University of Pittsburgh	Recruiting
	Pittsburgh, Pennsylvania, United States, 15213
	Contact: Nancy McLaughlin 412-246-6008 mclaughlinn@upmc.edu
	Principal Investigator: Benoit Mulsant, MD
	Sub-Investigator: Ariel Gildengers, MD

United States, Texas
	Baylor College of Medicine	Recruiting
	Houston, Texas, United States, 77030
	Contact: Barbara Kertz 713-794-8815 bkertz@bcm.tmc.edu
	Principal Investigator: Mark Kunik, MD

Canada, Ontario
	Centre for Addiction and Mental Health	Recruiting
	Toronto, Ontario, Canada, M6J1H4
	Contact: Dielle Miranda 416-535-8501 ext 3120 dielle_miranda@camh.net
	Principal Investigator: Bruce Pollock, MD, PhD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Study Chair:	Robert Young, MD	Cornell University

More Information

Responsible Party:	Weill Cornell Medical College ( Robert Young, MD/Principal Investigator )
Study ID Numbers:	U01 MH 68844-01A2, DATR A4-GPX
First Received:	November 14, 2005
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00254488
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Affective Disorders, Psychotic

Mental Disorders

Bipolar Disorder

Mood Disorders

Lithium Carbonate

Psychotic Disorders

Valproic Acid

Lithium

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00254488