Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abbott | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II disorder and are currently experiencing an episode of major depression. Patients are randomized to double-blind treatment with divalproex sodium ER or placebo and remain in the study for up to six weeks. This six-week double-blind treatment period is followed by an open-label treatment period of six months duration. This study is sponsored by Abbott Laboratories.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Divalproex Sodium ER | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divalproex Sodium ER | Drug | Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | MADRS total scores range from 0-60, where higher scores are indicative of more depression. | Acute phase (week0-week6) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Young Mania Rating Scale (YMRS) Total Score | YMRS Scores range from 0 to 60 where higher scores are indicative of more mania. | Acute phase (week0-week6) |
| Change in General Behavior Inventory (GBI) Depression Scale Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Keming Gao, MD, PhD | Case Western Reserve University / University Hospitals of Cleveland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20816041 | Derived | Muzina DJ, Gao K, Kemp DE, Khalife S, Ganocy SJ, Chan PK, Serrano MB, Conroy CM, Calabrese JR. Acute efficacy of divalproex sodium versus placebo in mood stabilizer-naive bipolar I or II depression: a double-blind, randomized, placebo-controlled trial. J Clin Psychiatry. 2011 Jun;72(6):813-9. doi: 10.4088/JCP.09m05570gre. Epub 2010 Aug 24. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Divalproex Sodium ER | Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher. |
| FG001 | Placebo | Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Divalproex Sodium ER | Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher. |
| 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 | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | MADRS total scores range from 0-60, where higher scores are indicative of more depression. | Posted | Least Squares Mean | Standard Error | units on a scale | Acute phase (week0-week6) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Divalproex Sodium ER | Divalproex Sodium ER: Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Keming Gao | Univeristy Hospitals Case Medical Center | 216-844-2865 | Keming.Gao@uhhospitals.org |
Not provided
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo | Drug | . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher. |
|
GBI Depression Scale Scores range from 46-184, where higher scores are indicative of more depression.
| Acute phase (week0-week6) |
| Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score | GBI Hypomanic/Biphasic Scale scores range from 28-112, where higher scores are indicative of more hypomanic/manic symptoms. | Acute phase (week0-week6) |
| Change in Short Form Health Survey (SF-36) Physical Component Summary Score | SF-36 Physical Component Summary scores range from 0-100, with a higher score indicating better physical health. | Acute phase (week0-week6) |
| Change in Short Form Health Survey (SF-36) Mental Component Summary Score | SF-36 Mental Component Summary scores range from 0-100, with a higher score indicating better mental health. | Acute phase (week0-week6) |
| Change in Hamilton Anxiety Rating Scale (HAMA) Total Score | HAMA Scores range from 0 to 56 where higher scores are indicative of more anxiety. | Acute phase (week0-week6) |
| BG001 | Placebo | Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| DSM-IV Diagnosis | Count of Participants | Participants |
|
Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
|
|
| Secondary | Change in Young Mania Rating Scale (YMRS) Total Score | YMRS Scores range from 0 to 60 where higher scores are indicative of more mania. | Posted | Mean | Standard Deviation | units on a scale | Acute phase (week0-week6) |
|
|
|
| Secondary | Change in General Behavior Inventory (GBI) Depression Scale Score | GBI Depression Scale Scores range from 46-184, where higher scores are indicative of more depression. | Not all subjects completed the GBI at study end point | Posted | Mean | Standard Deviation | units on a scale | Acute phase (week0-week6) |
|
|
|
| Secondary | Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score | GBI Hypomanic/Biphasic Scale scores range from 28-112, where higher scores are indicative of more hypomanic/manic symptoms. | Not all subjects completed the GBI at study end point | Posted | Mean | Standard Deviation | units on a scale | Acute phase (week0-week6) |
|
|
|
| Secondary | Change in Short Form Health Survey (SF-36) Physical Component Summary Score | SF-36 Physical Component Summary scores range from 0-100, with a higher score indicating better physical health. | Not all subjects completed the SF-36 at study end point | Posted | Mean | Standard Deviation | units on a scale | Acute phase (week0-week6) |
|
|
|
| Secondary | Change in Short Form Health Survey (SF-36) Mental Component Summary Score | SF-36 Mental Component Summary scores range from 0-100, with a higher score indicating better mental health. | Not all subjects completed the SF-36 at study end point | Posted | Mean | Standard Deviation | units on a scale | Acute phase (week0-week6) |
|
|
|
| Secondary | Change in Hamilton Anxiety Rating Scale (HAMA) Total Score | HAMA Scores range from 0 to 56 where higher scores are indicative of more anxiety. | Posted | Mean | Standard Deviation | units on a scale | Acute phase (week0-week6) |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 13 |
| 26 |
| EG001 | Placebo | Placebo: . Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher. | 0 | 28 | 0 | 28 | 5 | 28 |
| Increased Appetite | General disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Dry Mouth | General disorders | Non-systematic Assessment |
|
| Stomach Cramps | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |