Trial Outcomes & Findings for Treatment of Bipolar Mania in Older Adults (NCT NCT00254488)
NCT ID: NCT00254488
Last Updated: 2018-09-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
224 participants
Primary outcome timeframe
Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9
Results posted on
2018-09-25
Participant Flow
Participant milestones
| Measure |
Lithium
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).
|
Divalproex
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).
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
112
|
|
Overall Study
COMPLETED
|
55
|
63
|
|
Overall Study
NOT COMPLETED
|
57
|
49
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Bipolar Mania in Older Adults
Baseline characteristics by cohort
| Measure |
Lithium (LI)
n=112 Participants
Participants will receive 9 weeks of treatment with Lithium. The starting Lithium dose will be 150 mg in the morning and evening.
|
Divalproex (DV)
n=112 Participants
Participants will receive 9 weeks of treatment with Divalproex. The starting Divalproex dose will be 250 mg in the morning and evening.
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
68.3 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
68.0 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Young Mania Rating Scale
|
27.1 units on a scale
STANDARD_DEVIATION 7.4 • n=5 Participants
|
25.5 units on a scale
STANDARD_DEVIATION 6.1 • n=7 Participants
|
26.3 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sedation score
|
.5 units on a scale
STANDARD_DEVIATION .7 • n=5 Participants
|
.5 units on a scale
STANDARD_DEVIATION .6 • n=7 Participants
|
.5 units on a scale
STANDARD_DEVIATION .65 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9Population: The number of participants analyzed over the course of the study decreases due to participants missing a visit or dropping from the study.
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).
Outcome measures
| Measure |
Lithium (LI)
n=107 Participants
Participants will receive 9 weeks of treatment with Lithium. The starting Lithium dose will be 150 mg in the morning and evening.
|
Divalproex (DV)
n=109 Participants
Participants will receive 9 weeks of treatment with Divalproex. The starting Divalproex dose will be 250 mg in the morning and evening.
|
|---|---|---|
|
Sedation Score
Day 4
|
0.5 units on a scale
Standard Deviation 0.7
|
0.5 units on a scale
Standard Deviation 0.7
|
|
Sedation Score
Day 9
|
0.6 units on a scale
Standard Deviation 0.7
|
0.6 units on a scale
Standard Deviation 0.6
|
|
Sedation Score
Day 15
|
0.4 units on a scale
Standard Deviation 0.6
|
0.5 units on a scale
Standard Deviation 0.7
|
|
Sedation Score
Week 3
|
0.5 units on a scale
Standard Deviation 0.7
|
0.6 units on a scale
Standard Deviation 0.7
|
|
Sedation Score
Week 4
|
0.5 units on a scale
Standard Deviation 0.7
|
0.5 units on a scale
Standard Deviation 0.6
|
|
Sedation Score
Week 5
|
0.5 units on a scale
Standard Deviation 0.7
|
0.4 units on a scale
Standard Deviation 0.6
|
|
Sedation Score
Week 6
|
0.5 units on a scale
Standard Deviation 0.7
|
0.5 units on a scale
Standard Deviation 0.6
|
|
Sedation Score
Week 7
|
0.4 units on a scale
Standard Deviation 0.6
|
0.4 units on a scale
Standard Deviation 0.5
|
|
Sedation Score
Week 8
|
0.4 units on a scale
Standard Deviation 0.6
|
0.3 units on a scale
Standard Deviation 0.5
|
|
Sedation Score
Week 9
|
0.4 units on a scale
Standard Deviation 0.6
|
0.4 units on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9Population: The number of participants analyzed over the course of the study decreases due to participants missing a visit or dropping from the study.
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.
Outcome measures
| Measure |
Lithium (LI)
n=108 Participants
Participants will receive 9 weeks of treatment with Lithium. The starting Lithium dose will be 150 mg in the morning and evening.
|
Divalproex (DV)
n=109 Participants
Participants will receive 9 weeks of treatment with Divalproex. The starting Divalproex dose will be 250 mg in the morning and evening.
|
|---|---|---|
|
Young Mania Rating Scale (YMRS) Scores
Day 4
|
21.4 units on a scale
Standard Deviation 9.3
|
19.7 units on a scale
Standard Deviation 7.7
|
|
Young Mania Rating Scale (YMRS) Scores
Day 9
|
19.0 units on a scale
Standard Deviation 9.5
|
16.3 units on a scale
Standard Deviation 8.1
|
|
Young Mania Rating Scale (YMRS) Scores
Day 15
|
14.3 units on a scale
Standard Deviation 9.3
|
15.2 units on a scale
Standard Deviation 8.7
|
|
Young Mania Rating Scale (YMRS) Scores
Week 3
|
12.1 units on a scale
Standard Deviation 8.8
|
13.1 units on a scale
Standard Deviation 9.4
|
|
Young Mania Rating Scale (YMRS) Scores
Week 4
|
9.4 units on a scale
Standard Deviation 5.9
|
9.9 units on a scale
Standard Deviation 7.1
|
|
Young Mania Rating Scale (YMRS) Scores
Week 5
|
7.6 units on a scale
Standard Deviation 5.8
|
9.8 units on a scale
Standard Deviation 7.0
|
|
Young Mania Rating Scale (YMRS) Scores
Week 6
|
7.2 units on a scale
Standard Deviation 5.4
|
8.2 units on a scale
Standard Deviation 6.5
|
|
Young Mania Rating Scale (YMRS) Scores
Week 7
|
6.0 units on a scale
Standard Deviation 6.0
|
7.0 units on a scale
Standard Deviation 5.9
|
|
Young Mania Rating Scale (YMRS) Scores
Week 8
|
6.0 units on a scale
Standard Deviation 5.4
|
6.7 units on a scale
Standard Deviation 5.8
|
|
Young Mania Rating Scale (YMRS) Scores
Week 9
|
6.3 units on a scale
Standard Deviation 6.0
|
6.8 units on a scale
Standard Deviation 5.9
|
Adverse Events
Lithium (LI)
Serious events: 24 serious events
Other events: 69 other events
Deaths: 0 deaths
Divalproex (DV)
Serious events: 22 serious events
Other events: 70 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Lithium (LI)
n=112 participants at risk
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).
|
Divalproex (DV)
n=112 participants at risk
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).
|
|---|---|---|
|
Psychiatric disorders
Psychiatric condition worsening
|
8.0%
9/112 • Number of events 9 • 9 weeks
Clinicaltrials.gov definitions apply.
|
9.8%
11/112 • Number of events 12 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Hepatobiliary disorders
Elevated liver enzymes
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Vascular disorders
Circulatory condition
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
1.8%
2/112 • Number of events 3 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Cardiac disorders
Chest pain
|
1.8%
2/112 • Number of events 2 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Psychiatric disorders
Suicide
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Hospitalization for rectal bleeding
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Blood and lymphatic system disorders
Hospitalization for cellulitis
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Infections and infestations
Hospitalization for Urinary Tract infection
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Respiratory, thoracic and mediastinal disorders
Medical intervention for Bronchitis
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Metabolism and nutrition disorders
Medical complications due to alcohol abuse
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
numbness
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Investigations
Increased creatine level
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
General disorders
Unsteady gait with a subsequent fall, increased confusion and tremulousness
|
1.8%
2/112 • Number of events 2 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
General disorders
Edema
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Cardiac disorders
Hypertension
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Vascular disorders
Low blood pressure
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Surgical and medical procedures
Back surgery
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Nausea and vomitting
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
Other adverse events
| Measure |
Lithium (LI)
n=112 participants at risk
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).
|
Divalproex (DV)
n=112 participants at risk
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).
|
|---|---|---|
|
Metabolism and nutrition disorders
Elevated glucose
|
3.6%
4/112 • Number of events 8 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Metabolism and nutrition disorders
Decrease in sodium
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Cardiac disorders
Cardiac change
|
5.4%
6/112 • Number of events 6 • 9 weeks
Clinicaltrials.gov definitions apply.
|
4.5%
5/112 • Number of events 5 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Metabolism and nutrition disorders
Calcium Deficiency
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Endocrine disorders
Change in Thyroid level
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
21.4%
24/112 • Number of events 33 • 9 weeks
Clinicaltrials.gov definitions apply.
|
23.2%
26/112 • Number of events 35 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Infections and infestations
Infection
|
3.6%
4/112 • Number of events 6 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Injury, poisoning and procedural complications
Fall
|
17.0%
19/112 • Number of events 27 • 9 weeks
Clinicaltrials.gov definitions apply.
|
17.9%
20/112 • Number of events 27 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Injury, poisoning and procedural complications
Accidental injury
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Investigations
weight gain
|
11.6%
13/112 • Number of events 14 • 9 weeks
Clinicaltrials.gov definitions apply.
|
20.5%
23/112 • Number of events 27 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Investigations
Weight loss
|
11.6%
13/112 • Number of events 15 • 9 weeks
Clinicaltrials.gov definitions apply.
|
5.4%
6/112 • Number of events 6 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Investigations
Change in pre existing high blood pressure
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
1.8%
2/112 • Number of events 2 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Investigations
Change in Amylase and Lipase lab values
|
5.4%
6/112 • Number of events 8 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Investigations
Increased creatine level in lab work
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Investigations
Nosebleed
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
4.5%
5/112 • Number of events 5 • 9 weeks
Clinicaltrials.gov definitions apply.
|
5.4%
6/112 • Number of events 6 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Investigations
laboratory finding Increased liver enzymes
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
2.7%
3/112 • Number of events 3 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Investigations
laboratory findings increased white blood count
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
2.7%
3/112 • Number of events 3 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Psychiatric disorders
Worsening psychiatric symptoms
|
1.8%
2/112 • Number of events 6 • 9 weeks
Clinicaltrials.gov definitions apply.
|
4.5%
5/112 • Number of events 10 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Renal and urinary disorders
Elevated blood levels
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
3.6%
4/112 • Number of events 4 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Renal and urinary disorders
Urinary dysfunction
|
5.4%
6/112 • Number of events 6 • 9 weeks
Clinicaltrials.gov definitions apply.
|
2.7%
3/112 • Number of events 3 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptoms
|
6.2%
7/112 • Number of events 8 • 9 weeks
Clinicaltrials.gov definitions apply.
|
5.4%
6/112 • Number of events 6 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
1.8%
2/112 • Number of events 2 • 9 weeks
Clinicaltrials.gov definitions apply.
|
6.2%
7/112 • Number of events 8 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Vascular disorders
Hypertension
|
2.7%
3/112 • Number of events 5 • 9 weeks
Clinicaltrials.gov definitions apply.
|
3.6%
4/112 • Number of events 7 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Eye disorders
Vision disturbance
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.00%
0/112 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Tremor
|
6.2%
7/112 • Number of events 10 • 9 weeks
Clinicaltrials.gov definitions apply.
|
1.8%
2/112 • Number of events 4 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Sedation
|
6.2%
7/112 • Number of events 7 • 9 weeks
Clinicaltrials.gov definitions apply.
|
2.7%
3/112 • Number of events 5 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Decreased need for sleep
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Memory Change
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Headache
|
4.5%
5/112 • Number of events 5 • 9 weeks
Clinicaltrials.gov definitions apply.
|
2.7%
3/112 • Number of events 4 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Dizziness
|
2.7%
3/112 • Number of events 4 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 2 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Restlessness
|
1.8%
2/112 • Number of events 2 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Sinus tension
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
0.89%
1/112 • Number of events 1 • 9 weeks
Clinicaltrials.gov definitions apply.
|
Additional Information
Robert C. Young, MD, Professor of Psychiatry
Weill Cornell Medical College
Phone: 914-997-5886
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place