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Treatment of Bipolar Mania in Older Adults (GERI-BD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00254488
Recruitment Status : Completed
First Posted : November 16, 2005
Results First Posted : August 14, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Mania
Interventions Drug: Lithium (LI)
Drug: Divalproex (DV)
Enrollment 224
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lithium Divalproex
Hide Arm/Group Description

Participants will receive 9 weeks of treatment with lithium

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).

Participants will receive 9 weeks of treatment with divalproex

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).

Period Title: Overall Study
Started 112 112
Completed 55 63
Not Completed 57 49
Arm/Group Title Lithium (LI) Divalproex (DV) Total
Hide Arm/Group Description Participants will receive 9 weeks of treatment with Lithium. The starting Lithium dose will be 150 mg in the morning and evening. Participants will receive 9 weeks of treatment with Divalproex. The starting Divalproex dose will be 250 mg in the morning and evening. Total of all reporting groups
Overall Number of Baseline Participants 112 112 224
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 112 participants 224 participants
67.6  (6.8) 68.3  (6.1) 68.0  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 112 participants 224 participants
Female
56
  50.0%
59
  52.7%
115
  51.3%
Male
56
  50.0%
53
  47.3%
109
  48.7%
Young Mania Rating Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 112 participants 112 participants 224 participants
27.1  (7.4) 25.5  (6.1) 26.3  (6.8)
[1]
Measure Description: The Young Mania Rating Scale (YMRS) 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.
Sedation score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 112 participants 112 participants 224 participants
.5  (.7) .5  (.6) .5  (.65)
[1]
Measure Description: 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).
1.Primary Outcome
Title Sedation Score
Hide Description 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).
Time Frame Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed over the course of the study decreases due to participants missing a visit or dropping from the study.
Arm/Group Title Lithium (LI) Divalproex (DV)
Hide Arm/Group Description:
Participants will receive 9 weeks of treatment with Lithium. The starting Lithium dose will be 150 mg in the morning and evening.
Participants will receive 9 weeks of treatment with Divalproex. The starting Divalproex dose will be 250 mg in the morning and evening.
Overall Number of Participants Analyzed 107 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 4 Number Analyzed 107 participants 109 participants
0.5  (0.7) 0.5  (0.7)
Day 9 Number Analyzed 105 participants 99 participants
0.6  (0.7) 0.6  (0.6)
Day 15 Number Analyzed 98 participants 95 participants
0.4  (0.6) 0.5  (0.7)
Week 3 Number Analyzed 93 participants 91 participants
0.5  (0.7) 0.6  (0.7)
Week 4 Number Analyzed 75 participants 81 participants
0.5  (0.7) 0.5  (0.6)
Week 5 Number Analyzed 66 participants 78 participants
0.5  (0.7) 0.4  (0.6)
Week 6 Number Analyzed 61 participants 73 participants
0.5  (0.7) 0.5  (0.6)
Week 7 Number Analyzed 60 participants 67 participants
0.4  (0.6) 0.4  (0.5)
Week 8 Number Analyzed 54 participants 63 participants
0.4  (0.6) 0.3  (0.5)
Week 9 Number Analyzed 55 participants 63 participants
0.4  (0.6) 0.4  (0.6)
2.Primary Outcome
Title Young Mania Rating Scale (YMRS) Scores
Hide Description 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.
Time Frame Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed over the course of the study decreases due to participants missing a visit or dropping from the study.
Arm/Group Title Lithium (LI) Divalproex (DV)
Hide Arm/Group Description:
Participants will receive 9 weeks of treatment with Lithium. The starting Lithium dose will be 150 mg in the morning and evening.
Participants will receive 9 weeks of treatment with Divalproex. The starting Divalproex dose will be 250 mg in the morning and evening.
Overall Number of Participants Analyzed 108 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 4 Number Analyzed 108 participants 109 participants
21.4  (9.3) 19.7  (7.7)
Day 9 Number Analyzed 107 participants 99 participants
19.0  (9.5) 16.3  (8.1)
Day 15 Number Analyzed 96 participants 100 participants
14.3  (9.3) 15.2  (8.7)
Week 3 Number Analyzed 95 participants 92 participants
12.1  (8.8) 13.1  (9.4)
Week 4 Number Analyzed 76 participants 82 participants
9.4  (5.9) 9.9  (7.1)
Week 5 Number Analyzed 68 participants 79 participants
7.6  (5.8) 9.8  (7.0)
Week 6 Number Analyzed 60 participants 73 participants
7.2  (5.4) 8.2  (6.5)
Week 7 Number Analyzed 60 participants 67 participants
6.0  (6.0) 7.0  (5.9)
Week 8 Number Analyzed 54 participants 63 participants
6.0  (5.4) 6.7  (5.8)
Week 9 Number Analyzed 55 participants 63 participants
6.3  (6.0) 6.8  (5.9)
Time Frame 9 weeks
Adverse Event Reporting Description Clinicaltrials.gov definitions apply.
 
Arm/Group Title Lithium (LI) Divalproex (DV)
Hide Arm/Group Description

Participants will receive 9 weeks of treatment with lithium.

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).

Participants will receive 9 weeks of treatment with divalproex.

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).

All-Cause Mortality
Lithium (LI) Divalproex (DV)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/112 (0.00%)      2/112 (1.79%)    
Hide Serious Adverse Events
Lithium (LI) Divalproex (DV)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/112 (21.43%)      22/112 (19.64%)    
Blood and lymphatic system disorders     
Hospitalization for cellulitis  1  0/112 (0.00%)  0 1/112 (0.89%)  1
Cardiac disorders     
Chest pain  1  2/112 (1.79%)  2 1/112 (0.89%)  1
Hypertension  1  1/112 (0.89%)  1 0/112 (0.00%)  0
Gastrointestinal disorders     
Hospitalization for rectal bleeding  1  0/112 (0.00%)  0 1/112 (0.89%)  1
Nausea and vomitting  1  1/112 (0.89%)  1 0/112 (0.00%)  0
General disorders     
Unsteady gait with a subsequent fall, increased confusion and tremulousness  1  2/112 (1.79%)  2 0/112 (0.00%)  0
Edema  1  1/112 (0.89%)  1 0/112 (0.00%)  0
Hepatobiliary disorders     
Elevated liver enzymes  1  0/112 (0.00%)  0 1/112 (0.89%)  1
Infections and infestations     
Hospitalization for Urinary Tract infection  1  0/112 (0.00%)  0 1/112 (0.89%)  1
Investigations     
Increased creatine level  1  1/112 (0.89%)  1 0/112 (0.00%)  0
Metabolism and nutrition disorders     
Medical complications due to alcohol abuse  1  0/112 (0.00%)  0 1/112 (0.89%)  1
Nervous system disorders     
numbness  1  1/112 (0.89%)  1 1/112 (0.89%)  1
Psychiatric disorders     
Psychiatric condition worsening  1 [1]  9/112 (8.04%)  9 11/112 (9.82%)  12
Suicide  1 [2]  0/112 (0.00%)  0 1/112 (0.89%)  1
Respiratory, thoracic and mediastinal disorders     
pulmonary edema  1  1/112 (0.89%)  1 0/112 (0.00%)  0
Medical intervention for Bronchitis  1  1/112 (0.89%)  1 1/112 (0.89%)  1
Skin and subcutaneous tissue disorders     
Rash  1  1/112 (0.89%)  1 0/112 (0.00%)  0
Surgical and medical procedures     
Back surgery  1  1/112 (0.89%)  1 0/112 (0.00%)  0
Vascular disorders     
Circulatory condition  1  1/112 (0.89%)  1 2/112 (1.79%)  3
Low blood pressure  1  1/112 (0.89%)  1 0/112 (0.00%)  0
1
Term from vocabulary, MedDRA 12.1
Indicates events were collected by systematic assessment
[1]
Psychiatric Hospitalization due to worsening condition
[2]
One completed suicide after study completion
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.89%
Lithium (LI) Divalproex (DV)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   69/112 (61.61%)      70/112 (62.50%)    
Cardiac disorders     
Cardiac change  1  6/112 (5.36%)  6 5/112 (4.46%)  5
Endocrine disorders     
Change in Thyroid level  1  1/112 (0.89%)  1 0/112 (0.00%)  0
Eye disorders     
Vision disturbance  1  1/112 (0.89%)  1 0/112 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal symptoms  1  24/112 (21.43%)  33 26/112 (23.21%)  35
Infections and infestations     
Infection  1  4/112 (3.57%)  6 1/112 (0.89%)  1
Injury, poisoning and procedural complications     
Fall  1  19/112 (16.96%)  27 20/112 (17.86%)  27
Accidental injury  1  1/112 (0.89%)  1 0/112 (0.00%)  0
Investigations     
weight gain  1  13/112 (11.61%)  14 23/112 (20.54%)  27
Weight loss  1  13/112 (11.61%)  15 6/112 (5.36%)  6
Change in pre existing high blood pressure  1  0/112 (0.00%)  0 2/112 (1.79%)  2
Change in Amylase and Lipase lab values  1  6/112 (5.36%)  8 0/112 (0.00%)  0
Increased creatine level in lab work  1  1/112 (0.89%)  1 0/112 (0.00%)  0
Nosebleed  1  1/112 (0.89%)  1 0/112 (0.00%)  0
laboratory finding Increased liver enzymes  1  0/112 (0.00%)  0 3/112 (2.68%)  3
laboratory findings increased white blood count  1  0/112 (0.00%)  0 3/112 (2.68%)  3
Metabolism and nutrition disorders     
Elevated glucose  1  4/112 (3.57%)  8 0/112 (0.00%)  0
Decrease in sodium  1  0/112 (0.00%)  0 1/112 (0.89%)  1
Calcium Deficiency  1  1/112 (0.89%)  1 0/112 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain  1  5/112 (4.46%)  5 6/112 (5.36%)  6
Nervous system disorders     
Tremor  1  7/112 (6.25%)  10 2/112 (1.79%)  4
Sedation  1  7/112 (6.25%)  7 3/112 (2.68%)  5
Decreased need for sleep  1  1/112 (0.89%)  1 1/112 (0.89%)  1
Memory Change  1  1/112 (0.89%)  1 1/112 (0.89%)  1
Headache  1  5/112 (4.46%)  5 3/112 (2.68%)  4
Dizziness  1  3/112 (2.68%)  4 1/112 (0.89%)  2
Restlessness  1  2/112 (1.79%)  2 1/112 (0.89%)  1
Sinus tension  1  1/112 (0.89%)  1 1/112 (0.89%)  1
Psychiatric disorders     
Worsening psychiatric symptoms  1  2/112 (1.79%)  6 5/112 (4.46%)  10
Renal and urinary disorders     
Elevated blood levels  1  0/112 (0.00%)  0 4/112 (3.57%)  4
Urinary dysfunction  1  6/112 (5.36%)  6 3/112 (2.68%)  3
Reproductive system and breast disorders     
Sexual dysfunction  1  1/112 (0.89%)  1 1/112 (0.89%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory symptoms  1  7/112 (6.25%)  8 6/112 (5.36%)  6
Skin and subcutaneous tissue disorders     
Skin disorder  1  2/112 (1.79%)  2 7/112 (6.25%)  8
Vascular disorders     
Hypertension  1  3/112 (2.68%)  5 4/112 (3.57%)  7
1
Term from vocabulary, MedDRA 12.1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert C. Young, MD, Professor of Psychiatry
Organization: Weill Cornell Medical College
Phone: 914-997-5886
EMail: ryoung@med.cornell.edu
Publications of Results:
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00254488    
Other Study ID Numbers: U01MH068847 ( U.S. NIH Grant/Contract )
U01MH068847 ( U.S. NIH Grant/Contract )
First Submitted: November 14, 2005
First Posted: November 16, 2005
Results First Submitted: July 19, 2018
Results First Posted: August 14, 2018
Last Update Posted: September 25, 2018