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| ID | Type | Description | Link |
|---|---|---|---|
| U01MH068847 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium (LI) | Experimental | Participants will receive 9 weeks of treatment with lithium |
|
| Divalproex (DV) | Experimental | Participants will receive 9 weeks of treatment with divalproex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Young, MD | Cornell University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Precise Research Centers | Flowood | Mississippi | 39232 | United States | ||
| Weill Cornell Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22467848 | Result | 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. | |
| 24664811 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lithium (LI) | Participants will receive 9 weeks of treatment with Lithium. The starting Lithium dose will be 150 mg in the morning and evening. |
| BG001 | Divalproex (DV) | Participants will receive 9 weeks of treatment with Divalproex. The starting Divalproex dose will be 250 mg in the morning and evening. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The number of participants analyzed over the course of the study decreases due to participants missing a visit or dropping from the study. | Posted | Mean | Standard Deviation | units on a scale | Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9 |
|
9 weeks
Clinicaltrials.gov definitions apply.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lithium (LI) | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric condition worsening | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment | Psychiatric Hospitalization due to worsening condition |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated glucose | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert C. Young, MD, Professor of Psychiatry | Weill Cornell Medical College | 914-997-5886 | ryoung@med.cornell.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D008094 | Lithium |
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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|
| 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). |
|
|
| White Plains |
| New York |
| 10605 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Centre for Addiction and Mental Health | Toronto | Ontario | M6J1H4 | Canada |
| 21360754 | Result | 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. |
| 21176032 | Result | 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. |
| 20148867 | Result | 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. |
| 29088928 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Young Mania Rating Scale | 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. | Mean | Standard Deviation | units on a scale |
|
| 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). | Mean | Standard Deviation | units on a scale |
|
Participants will receive 9 weeks of treatment with Divalproex. The starting Divalproex dose will be 250 mg in the morning and evening.
|
|
| Primary | 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. | The number of participants analyzed over the course of the study decreases due to participants missing a visit or dropping from the study. | Posted | Mean | Standard Deviation | units on a scale | Day 4, Day 9, Day 15, and then Weekly from Week 3 to Week 9 |
|
|
|
| 0 |
| 112 |
| 24 |
| 112 |
| 69 |
| 112 |
| EG001 | Divalproex (DV) | 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). | 2 | 112 | 22 | 112 | 70 | 112 |
|
| Elevated liver enzymes | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Circulatory condition | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chest pain | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Suicide | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment | One completed suicide after study completion |
|
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hospitalization for rectal bleeding | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hospitalization for cellulitis | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hospitalization for Urinary Tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Medical intervention for Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Medical complications due to alcohol abuse | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| numbness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Increased creatine level | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Unsteady gait with a subsequent fall, increased confusion and tremulousness | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Edema | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Hypertension | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Low blood pressure | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back surgery | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea and vomitting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Decrease in sodium | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cardiac change | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Calcium Deficiency | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
|
| Change in Thyroid level | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastrointestinal symptoms | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Accidental injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| weight gain | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Weight loss | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Change in pre existing high blood pressure | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Change in Amylase and Lipase lab values | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Increased creatine level in lab work | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Nosebleed | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| laboratory finding Increased liver enzymes | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| laboratory findings increased white blood count | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Worsening psychiatric symptoms | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Elevated blood levels | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Urinary dysfunction | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sexual dysfunction | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Respiratory symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vision disturbance | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Decreased need for sleep | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Memory Change | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Restlessness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Sinus tension | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008670 |
| Metals |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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