Bipolar DisorderPhase 4GERI-BDNCT00254488

Treatment of Bipolar Mania in Older Adults

A Phase 4 study testing Lithium (LI) and Divalproex (DV) in people with Bipolar Disorder and Mania, run by Weill Medical College of Cornell University at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 60 years and older
Conditions the study is for: Bipolar Disorder, Mania
What is being tested?: Lithium (LI) and Divalproex (DV)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 224 participants
Where: 8 sitesin 2 countries
Study dates: Nov 2005to Aug 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

United States7 sites

University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Duke University Medical Center
Durham, North Carolina, 27710
Precise Research Centers
Flowood, Mississippi, 39232
Baylor College of Medicine
Houston, Texas, 77030
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Weill Cornell Medical College
White Plains, New York, 10605

Other trials in United States

Canada1 site

Centre for Addiction and Mental Health
Toronto, Ontario, M6J1H4

Other trials in Canada

About this study

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

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

Read the 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.

Conditions: Bipolar Disorder, Mania
Being tested: Lithium (LI), Divalproex (DV)
Medical subject headings: Bipolar Disorder, Mania

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lithium (LI)Drug
Also called Depakote
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)Drug
Also called Valproate
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).

Study groups in NCT00254488
Study group	Role	What they receive
Lithium (LI)	Experimental	Participants will receive 9 weeks of treatment with lithium Receives: Drug: Lithium (LI)
Divalproex (DV)	Experimental	Participants will receive 9 weeks of treatment with divalproex Receives: Drug: Divalproex (DV)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2005Aug 2011

First posted16 Nov 2005 (estimated)
Study startNov 2005
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00254488
Sponsor's protocol ID: U01MH068847
Other IDs: U01MH068847
Acronym: GERI-BD
Status last verified: Aug 2018
First submitted: 14 Nov 2005
Last updated: 25 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 22467848
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.
PubMed 24664811
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.
PubMed 21360754
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.
PubMed 21176032
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.
PubMed 20148867
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.
PubMed 29088928

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Pharmacotherapy of Late-Life Mania (GERI-BD)
ClinicalTrials.gov ID: NCT00254488
Acronym / sponsor ID: GERI-BD / U01MH068847
Conditions: Bipolar Disorder, Mania
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Nov 2005
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 16 Nov 2005 (estimated)
Results: Posted 14 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Lithium (LI)	Experimental	Drug: Lithium (LI)Participants will receive 9 weeks of treatment with lithium
Divalproex (DV)	Experimental	Drug: Divalproex (DV)Participants will receive 9 weeks of treatment with divalproex

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lithium (LI)Also: DepakoteThe 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).	Drug	Lithium (LI)
Divalproex (DV)Also: ValproateDosage 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).	Drug	Divalproex (DV)

Primary outcome

Sedation Score
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 14 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lithium	112	55
Divalproex	112	63

Primary outcome: Sedation Score

Time frame: Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9. Mean (Standard Deviation). Unit: units on a scale

Measure	Lithium (LI) n = 107	Divalproex (DV) n = 109
Day 4	0.5 (0.7)	0.5 (0.7)
Day 9	0.6 (0.7)	0.6 (0.6)
Day 15	0.4 (0.6)	0.5 (0.7)
Week 3	0.5 (0.7)	0.6 (0.7)
Week 4	0.5 (0.7)	0.5 (0.6)
Week 5	0.5 (0.7)	0.4 (0.6)
Week 6	0.5 (0.7)	0.5 (0.6)
Week 7	0.4 (0.6)	0.4 (0.5)

Population analysed: The number of participants analyzed over the course of the study decreases due to participants missing a visit or dropping from the study.

Primary outcome: Young Mania Rating Scale (YMRS) Scores

Time frame: Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9. Mean (Standard Deviation). Unit: units on a scale

Measure	Lithium (LI) n = 108	Divalproex (DV) n = 109
Day 4	21.4 (9.3)	19.7 (7.7)
Day 9	19.0 (9.5)	16.3 (8.1)
Day 15	14.3 (9.3)	15.2 (8.7)
Week 3	12.1 (8.8)	13.1 (9.4)
Week 4	9.4 (5.9)	9.9 (7.1)
Week 5	7.6 (5.8)	9.8 (7.0)
Week 6	7.2 (5.4)	8.2 (6.5)
Week 7	6.0 (6.0)	7.0 (5.9)

Population analysed: The number of participants analyzed over the course of the study decreases due to participants missing a visit or dropping from the study.

Adverse events

Time frame: 9 weeks. Other adverse events reported at 0.89% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lithium (LI)	24 of 112 (21.4%)	69 of 112 (61.6%)	0 of 112
Divalproex (DV)	22 of 112 (19.6%)	70 of 112 (62.5%)	2 of 112

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22467848Al 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.
Results publication: PubMed 24664811Beyer 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.
Results publication: PubMed 21360754Sajatovic 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.
Results publication: PubMed 21176032Gildengers 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.
Results publication: PubMed 20148867Young 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.
Derived from this study: PubMed 29088928Young 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Young, MD study chair

Cornell University

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lithium (LI) and Divalproex (DV) in people with Bipolar Disorder and Mania, run by Weill Medical College of Cornell University at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sedation Score (time frame: Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00254488, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.