Trial Outcomes & Findings for The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder (NCT NCT00678574)

Results Overview

GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

45 participants

Primary outcome timeframe

2-3 months post-treatment w/ fluoxetine.

Results posted on

2018-07-27

Participant Flow

45 subjects were recruited at an outpatient practice at Yale University, CT.

Participant milestones

Participant milestones
Measure	PMDD Participants who qualified as having PMDD received fluoxetine 20 mg daily by mouth for 2-3 months	Healthy Controls Participants who did not qualify for a diagnosis of PMDD and did not receive drug treatment.
Overall Study STARTED	18	27
Overall Study COMPLETED	18	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PMDD Group n=18 Participants Fluoxetine 20 mg daily by mouth for 2-3 months to the PMDD group	Healthy Controls n=27 Participants No intervention was provided to the healthy control group.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=18 Participants	0 Participants n=27 Participants	0 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=18 Participants	27 Participants n=27 Participants	45 Participants n=45 Participants
Age, Categorical >=65 years	0 Participants n=18 Participants	0 Participants n=27 Participants	0 Participants n=45 Participants
Sex: Female, Male Female	18 Participants n=18 Participants	27 Participants n=27 Participants	45 Participants n=45 Participants
Sex: Female, Male Male	0 Participants n=18 Participants	0 Participants n=27 Participants	0 Participants n=45 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 2-3 months post-treatment w/ fluoxetine.

Population: This study was conducted at Yale several years ago. Our group at UPenn only has basic information about this study. This includes the number of participants, which was 18, and that no adverse events occurred. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania.

GABA levels would be assessed during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the SSRI.

Outcome measures

Outcome data not reported

Adverse Events

Fluoxetine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cynthia Neill Epperson, M.D.

University of Pennsylvania

Phone: 215-573-8871

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place