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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
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A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Flexible dose up to 2500mg per day, for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6. | Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60. | Baseline to week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6. | Change is observed value at each visit minus baseline value. MADRS is a 10-item instrument measuring depression: scale range between 0(normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. | Baseline to week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zubin Bhagwagar, MD PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17140277 | Background | Muralidharan A, Bhagwagar Z. Potential of levetiracetam in mood disorders: a preliminary review. CNS Drugs. 2006;20(12):969-79. doi: 10.2165/00023210-200620120-00002. | |
| 21034692 | Derived | Saricicek A, Maloney K, Muralidharan A, Ruf B, Blumberg HP, Sanacora G, Lorberg B, Pittman B, Bhagwagar Z. Levetiracetam in the management of bipolar depression: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Jun;72(6):744-50. doi: 10.4088/JCP.09m05659gre. Epub 2010 Oct 19. |
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Subjects were recruited from 2005-2008 from New Haven, CT and surrounding areas.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam | Subjects on active study medication. |
| FG001 | Placebo | Subjects assigned to placebo control group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam | Subjects on active study medication. |
| BG001 | Placebo | Subjects assigned to placebo control group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6. | Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60. | Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline. | Posted | Least Squares Mean | Standard Error | score on scale | Baseline to week 6 |
|
Adverse events were collected during course of the study and for two weeks after last study intervention.
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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 | Levetiracetam | Subjects on active study medication. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zubin Bhagwagar | Yale University | 203-974-7560 | zubin.bhagwagar@yale.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Placebo | Drug | Flexible dose up to 2500mg per day, for 6 weeks. |
|
| Number of Subjects Who Achieve Remission. |
Remission response is measured as an HDRS-21 total score is less than or equal to 7. HDRS-21 measures range of depressive symptoms. Endpoint is LOCF. |
| Week 6 |
| Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6. | Change is observed value at each visit minus baseline value. CGI-BP depression severity is an instrument which measures severity of depression in bipolar disorder. Scale range: 1=normal, not ill; 7=very severely ill | Baseline to week 6 |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects assigned to placebo control group. |
|
|
|
| Secondary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6. | Change is observed value at each visit minus baseline value. MADRS is a 10-item instrument measuring depression: scale range between 0(normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. | Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline. | Posted | Least Squares Mean | Standard Error | score on scale | Baseline to week 6 |
|
|
|
|
| Secondary | Number of Subjects Who Achieve Remission. | Remission response is measured as an HDRS-21 total score is less than or equal to 7. HDRS-21 measures range of depressive symptoms. Endpoint is LOCF. | Posted | Number | Participants | Week 6 |
|
|
|
|
| Secondary | Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6. | Change is observed value at each visit minus baseline value. CGI-BP depression severity is an instrument which measures severity of depression in bipolar disorder. Scale range: 1=normal, not ill; 7=very severely ill | Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline. | Posted | Least Squares Mean | Standard Error | score on scale | Baseline to week 6 |
|
|
|
|
| 0 |
| 19 |
| 17 |
| 19 |
| EG001 | Placebo | Subjects assigned to placebo control group. | 0 | 16 | 15 | 16 |
| GI symptoms | Gastrointestinal disorders | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | Non-systematic Assessment |
|
| Coordination | Nervous system disorders | Non-systematic Assessment |
|
| Shakiness | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Weakness | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
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| Hypomanic symptoms | Psychiatric disorders | Non-systematic Assessment |
|
| Worsening of depressive symptoms | Psychiatric disorders | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Slurred speech | Nervous system disorders | Non-systematic Assessment |
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| Sunstance Abuse Relapse | Psychiatric disorders | Non-systematic Assessment |
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| Increase in suicidality | Psychiatric disorders | Non-systematic Assessment |
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| Cognitive | Psychiatric disorders | Non-systematic Assessment |
|
| Drooling | Gastrointestinal disorders | Non-systematic Assessment |
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| Genitourinary | General disorders | Non-systematic Assessment |
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| Blurred vision | Nervous system disorders | Non-systematic Assessment |
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| Unusual dreams/nightmares | General disorders | Non-systematic Assessment |
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| Taste | Gastrointestinal disorders | Non-systematic Assessment |
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| Nosebleed | General disorders | Non-systematic Assessment |
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| Cardiac | Cardiac disorders | Non-systematic Assessment |
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| Rash | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle soreness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cold | General disorders | Non-systematic Assessment |
|
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Week 3 (n=13, n=14) |
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| Week 4 (n=11, n=13) |
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| Week 5 (n=11, n=12) |
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| Week 6 (n=10, n=11) |
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| Week 3 (n=13, n=14) |
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| Week 4 (n=11, n=13) |
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| Week 5 (n=11, n=12) |
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| Week 6 (n=10, n=10) |
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