The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder
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|ClinicalTrials.gov Identifier: NCT00678574|
Recruitment Status : Completed
First Posted : May 15, 2008
Results First Posted : July 17, 2017
Last Update Posted : July 27, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Premenstrual Dysphoric Disorder Premenstrual Syndrome||Drug: fluoxetine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder|
|Study Start Date :||March 1998|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Experimental: Premenstrual Dysphoric Disorder (PMDD) group
PMDD group received fluoxetine 20 mg daily by mouth for 2-3 months
Fluoxetine 20 mg daily by mouth for 2-3 months.
|No Intervention: Healthy controls|
- Change in Cortical Gama-aminobutyric Acid Levels (GABA Levels) Pre and Post SSRI Treatment [ Time Frame: 2-3 months post-treatment w/ fluoxetine. ]GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI.
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|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- Aged 18 - 45 years old and able to give voluntary written informed consent.
- Willing to complete a daily log of mood symptoms for 7 consecutive menstrual cycles: two menstrual cycles during the Screening Phase (Phase 1), one menstrual cycle during the Testing Phase (Phase 2), and four menstrual cycles during the Medication Treatment Phase and Post-Treatment Phase (Phase 3). All subjects who successfully complete Phases 1 and 2, and the Medication Treatment Phase, will be invited to participate in Phase 3 approximately three months later. Phase 3 will involve repeating all procedures conducted in Phase 2, including the daily log of mood symptoms.
- Meet DSM-IV criteria for premenstrual dysphoric disorder, confirmed by the Daily Record of Severity of Problems (DRSP; Endicott & Harrison) for 2 consecutive menstrual cycles (Phase 1). The DRSP is a self-rated symptom checklist, which requires individuals to rate their symptoms of PMDD according to the DSM-IV research criteria scale on a scale from 1 (symptom not present) to 6 (symptom extreme). During the last 7 days of the menstrual cycle compared to days 5-11, patients must have a 30% increase in their average (over 2 menstrual cycles) score for 5 of these 10 symptoms. Symptoms must be "not present" or "minimal" during the postmenstrual week.
- Average 19-item Hamilton Depression Rating Scale (HAM-D) scores < 5 during the follicular phase and > 16 during the luteal phase.
- Have regular menstrual cycles 28 to 32 days in length. Each of the screening cycles must be ovulatory as confirmed by plasma progesterone levels of >5 ng/ml during the luteal phase.
- Presence of any other comorbid DSM-IV Axis I disorder.
- Meeting DSM-IV criteria for psychoactive substance (excluding nicotine) dependence within the preceding 4 months.
- A history of serious medical or neurological illness, including (but not limited to) major cardiovascular disease, severe hypertension, intracranial mass lesions, seizure disorder, severe hepatic or renal disease, unstable endocrine or metabolic disease, and unstable hematologic disease.
- Use of anticonvulsant or benzodiazepines within the last month.
- Use of psychotropic medication in last week (except as stated above).
- Use of steroid contraceptives within the previous 4 months, including birth control pill, birth control patch, birth control ring, and Depo-Provera®. Subjects will be asked to use abstinence or the barrier method (condoms) as forms of contraception in this study.
- Alcohol consumption greater than 7 drinks/week.
- Current pregnancy.
- Metallic implants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678574
|United States, Connecticut|
|New Haven, Connecticut, United States, 06511|
|Principal Investigator:||Cynthia N Epperson, MD||University of Pennsylvania School of Medicine Department of Psychiatry|
|Responsible Party:||University of Pennsylvania|
|Other Study ID Numbers:||
|First Posted:||May 15, 2008 Key Record Dates|
|Results First Posted:||July 17, 2017|
|Last Update Posted:||July 27, 2018|
|Last Verified:||July 2017|
Premenstrual Dysphoric Disorder
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors