NCT00254488

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_4

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2005

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
7 years until next milestone

Results Posted

Study results publicly available

August 14, 2018

Completed
Last Updated

September 25, 2018

Status Verified

August 1, 2018

Enrollment Period

5.8 years

First QC Date

November 14, 2005

Results QC Date

July 19, 2018

Last Update Submit

August 27, 2018

Conditions

Bipolar DisorderMania

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Lithium (LI)

EXPERIMENTAL

Participants will receive 9 weeks of treatment with lithium

Drug: Lithium (LI)

Divalproex (DV)

EXPERIMENTAL

Participants will receive 9 weeks of treatment with divalproex

Drug: Divalproex (DV)

Interventions

Lithium (LI)DRUG

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).

Also known as: Depakote
Lithium (LI)
Divalproex (DV)DRUG

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).

Also known as: Valproate
Divalproex (DV)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

Weill Cornell Medical College

White Plains, New York, 10605, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Location

Related Publications (6)

  • 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. 2012 Mar;25(1):62-8. doi: 10.1177/0891988712436684.

    PMID: 22467848RESULT

  • 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.

    PMID: 24664811RESULT

  • 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.

    PMID: 21360754RESULT

  • 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 Disord. 2010 Dec;12(8):851-8. doi: 10.1111/j.1399-5618.2010.00877.x.

    PMID: 21176032RESULT

  • 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, controlled treatment trial for geriatric bipolar disorder: GERI-BD. Bipolar Disord. 2010 Feb;12(1):56-67. doi: 10.1111/j.1399-5618.2009.00779.x.

    PMID: 20148867RESULT

  • Young RC, Mulsant BH, Sajatovic M, Gildengers AG, Gyulai L, Al Jurdi RK, Beyer J, Evans J, Banerjee S, Greenberg R, Marino P, Kunik ME, Chen P, Barrett M, Schulberg HC, Bruce ML, Reynolds CF 3rd, Alexopoulos GS; GERI-BD Study Group. GERI-BD: A Randomized Double-Blind Controlled Trial of Lithium and Divalproex in the Treatment of Mania in Older Patients With Bipolar Disorder. Am J Psychiatry. 2017 Nov 1;174(11):1086-1093. doi: 10.1176/appi.ajp.2017.15050657. Epub 2017 Aug 4.

    PMID: 29088928DERIVED

MeSH Terms

Conditions

Bipolar DisorderMania

Interventions

LithiumValproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetalsPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Results Point of Contact

Title
Robert C. Young, MD, Professor of Psychiatry
Organization
Weill Cornell Medical College
ryoung@med.cornell.edu
914-997-5886

Study Officials

  • Robert Young, MD

    Cornell University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2005

First Posted

November 16, 2005

Study Start

November 1, 2005

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 25, 2018

Results First Posted

August 14, 2018

Record last verified: 2018-08

Locations

US(7)CA(1)