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| ID | Type | Description | Link |
|---|---|---|---|
| BMC03-010 |
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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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The purpose of this study is to investigate the clinical efficacy of Levetiracetam in the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in an open label study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label treatment | Experimental | Patients prospectively diagnosed with premenstrual dysphoric disorder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Levetiracetam was started at 250 mg qhs at the end of the first week of the follicular phase. Dose was gradually increased up to 1500 mg bid as tolerated or clinically effective. The treatment phase lasted 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Record of Severity of Problems (DRSP), Clinical Global Impression- Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I). | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| How Levetiracetam is tolerated, adverse events. | 4 months |
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Inclusion Criteria:
PMDD diagnostic and severity criteria:
Women with PMDD according to DSM-IV-TR criteria
The first 2 consecutive or 2 out of 3 consecutive qualification cycles must fulfill the following criteria:
For women who were not on any medications for the PMDD symptoms:
For women who were on anti-depressants or oral contraceptive for at least 2 months:
Absence of any one of the following Axis I disorders during the last 6 months:
Absence of any of the following Axis I disorders (current or history of), based on the Mini International Neuropsychiatric interview (MINI)
Other criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zerrin E Kayatekin, MD | Berkshire Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berkshire Medical Center, Clinical Trials Program, Department of Psychiatry | Pittsfield | Massachusetts | 01201 | United States |
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| ID | Term |
|---|---|
| D065446 | Premenstrual Dysphoric Disorder |
| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |