HealthyNCT00676026

Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women

A study testing Fluoxetine, Zolpidem and Progesterone in people with Healthy, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Fluoxetine, Zolpidem and Progesterone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: May 2005to Feb 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Women ages 18-45 and able to give voluntary written informed consent;
Regular menstrual periods of 24-35 days in length;
Body mass index 18.5 to 30 kg/m2;
No past or present DSM-IV psychiatric or substance dependence diagnosis by structured diagnostic interview (SCID-NP); no substance abuse history within the previous 2 years;
Absence of mood symptoms across the menstrual cycle during one month of prospective daily ratings with the Daily Record of Severity of Problems (DRSP); the DRSP is based on the DSM-IV research criteria for premenstrual dysphoric disorder (PMDD) and has been used in numerous studies to confirm the presence or absence of significant premenstrual mood and behavioral difficulties;
Must be willing and able to participate in at least three of the four challenge paradigms.

Who cannot join

Medical, neurologic or cerebrovascular disorder (CVA, seizure disorder, etc.);
Family history of first degree relative with an Axis I psychiatric or substance dependence disorder (excepting alcohol and nicotine) (per subject report);
Current treatment with psychoactive medication;
Diabetes controlled by means other than diet;
Use of steroid contraceptives (any method involving hormones) within the previous 4 months;
Habitual consumption of more than 7 alcoholic drinks per week or more than 2 drinks on any particular occasion; must be willing to abstain from alcohol consumption for 48 hours prior to each 1H-MRS scan;
Implanted metallic devices.

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale University School of Medicine; Yale Program for Women's Reproductive Behavioral Health
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: The Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women

The goal of this series of challenge studies is to examine the impact of menstrual cycle phase on cortical GABA response to administration of agents with either direct (benzodiazepines) or indirect (progesterone, fluoxetine) GABA modulating properties. While the impact of these agents on cortical GABA levels in women with premenstrual dysphoric disorder (PMDD) is of interest, this study is designed primarily for those women without a psychiatric illness.

Conditions: Healthy
Being tested: Fluoxetine, Zolpidem, Progesterone
Keywords: menses, women, healthy controls, Healthy females with regular menstrual cycles

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FluoxetineDrug
Also called Prozac
Fluoxetine 20 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.
ZolpidemDrug
Also called Ambien
Zolpidem 10 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.
ProgesteroneDrug
Also called Prometrium
Progesterone 800 mg by mouth will be administered to each participant once in the follicular and luteal phases of the menstrual cycle.

Study groups in NCT00676026
Study group	Role	What they receive
Zolpidem 1	Experimental	Zolpidem will be administered twice to each participant; once in the follicular and luteal phases of the menstrual cycle. Receives: Drug: Zolpidem
Progesterone 2	Experimental	Progesterone will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle. Receives: Drug: Progesterone
Fluoxetine 3	Experimental	Fluoxetine will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle. Receives: Drug: Fluoxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by Menstrual Cycle Phase as Measured Using 1H-MRS in Healthy Controls.
This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.
Measured: Each medication will be administered 2 times during a 1-month menstrual cycle.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2005Feb 2009

First posted12 May 2008 (estimated)
Study startMay 2005
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00676026
Sponsor's protocol ID: 0505027759
Status last verified: May 2017
First submitted: 7 Apr 2008
Last updated: 1 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women
ClinicalTrials.gov ID: NCT00676026
Acronym / sponsor ID: 0505027759
Conditions: Healthy
Keywords: menses, women, healthy controls, Healthy females with regular menstrual cycles
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: May 2005
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 12 May 2008 (estimated)
Results: Posted 1 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Zolpidem 1	Experimental	Drug: ZolpidemZolpidem will be administered twice to each participant; once in the follicular and luteal phases of the menstrual cycle.
Progesterone 2	Experimental	Drug: ProgesteroneProgesterone will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle.
Fluoxetine 3	Experimental	Drug: FluoxetineFluoxetine will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Women ages 18-45 and able to give voluntary written informed consent;
Regular menstrual periods of 24-35 days in length;
Body mass index 18.5 to 30 kg/m2;
No past or present DSM-IV psychiatric or substance dependence diagnosis by structured diagnostic interview (SCID-NP); no substance abuse history within the previous 2 years;
Absence of mood symptoms across the menstrual cycle during one month of prospective daily ratings with the Daily Record of Severity of Problems (DRSP); the DRSP is based on the DSM-IV research criteria for premenstrual dysphoric disorder (PMDD) and has been used in numerous studies to confirm the presence or absence of significant premenstrual mood and behavioral difficulties;

Key exclusion criteria (7 listed)

Medical, neurologic or cerebrovascular disorder (CVA, seizure disorder, etc.);
Family history of first degree relative with an Axis I psychiatric or substance dependence disorder (excepting alcohol and nicotine) (per subject report);
Current treatment with psychoactive medication;
Diabetes controlled by means other than diet;
Use of steroid contraceptives (any method involving hormones) within the previous 4 months;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FluoxetineAlso: ProzacFluoxetine 20 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.	Drug	Fluoxetine 3
ZolpidemAlso: AmbienZolpidem 10 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.	Drug	Zolpidem 1
ProgesteroneAlso: PrometriumProgesterone 800 mg by mouth will be administered to each participant once in the follicular and luteal phases of the menstrual cycle.	Drug	Progesterone 2

Primary outcome

To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by Menstrual Cycle Phase as Measured Using 1H-MRS in Healthy Controls.
Time frame: Each medication will be administered 2 times during a 1-month menstrual cycle.
This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.

Results and safety

Results posted to the registry on 1 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	8	8

Primary outcome: To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by Menstrual Cycle Phase as Measured Using 1H-MRS in Healthy Controls.

Time frame: Each medication will be administered 2 times during a 1-month menstrual cycle.

Population analysed: UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable.

Adverse events

Time frame: Entire study duration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cynthia N Epperson, MD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fluoxetine, Zolpidem and Progesterone in people with Healthy, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by Menstrual Cycle Phase as Measured Using 1H-MRS in Healthy Controls. (time frame: Each medication will be administered 2 times during a 1-month menstrual cycle.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00676026.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.