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A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria

Primary Purpose

Premenstrual Dysphoric Disorder, Premenstrual Syndrome

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

paroxetine

About this trial

This is an interventional treatment trial for Premenstrual Dysphoric Disorder focused on measuring paroxetine, onset of action, serotonin reuptake inhibitors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

The patient should have participated in an ongoing placebo-controlled trial regarding the effect of paroxetine in PMD; to be included in that trial, she must have fulfilled the diagnostic criteria A-C of PMDD in DSM-IV and certain other inclusion and exclusion criteria which are listed in appendix 1.
The patient should a) have been given paroxetine during the previous trial, b) have reported that she has been "much improved" or "very much improved" by this treatment, c) have displayed a marked reduction in VAS-rated irritability during treatment, and d) have reported that she has found the side-effects tolerable.
The patient should display at least a 50% increase in VAS-rated irritability during the luteal phase (mean of last five days prior to menses) as compared the follicular phase (days 6-10) during one cycle of pretreatment symptom rating (without medication).
The patient should have given written informed consent to participate in the study.

Exclusion Criteria:

Any concomitant psychiatric disorder for which SRIs are known to be effective.
Any other concomitant psychiatric disorder that, in the investigator's opinion, would render the patient unsuitable for the study.
Any somatic disorder that, in the investigator's opinion, would render the patient unsuitable for the study.
Any ongoing medication which, in the opinion of the investigator, would render the patient unsuitable for the study. Examples of medications that preclude participation in the study are: 1) any psychotropic drug, with the exception of the occasional use of hypnotics, 2) any hormonal preparation, with the exception of thyroid hormone, 3) anti-coagulants, and 4) 5HT1D agonists. Occasional use of analgesic compounds does not preclude participation.
Patient characteristics which, in the opinion of the investigator, are likely to reduce compliance with the protocol.

Sites / Locations

The Psychiatric clinic, Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Paroxetine 20mg during the luteal phase of the menstrual cycle

Placebo during the luteal phase of the menstrual cycle

Outcomes

Primary Outcome Measures

The number of patients reaching sustained remission (irritability) for each time point

Secondary Outcome Measures

Self rated irritability at each time point

Full Information

NCT ID

NCT00516113

First Posted

August 13, 2007

Last Updated

December 6, 2007

Sponsor

Karolinska Institutet

Collaborators

Novo Nordisk A/S, GlaxoSmithKline, Göteborg University

1. Study Identification

Unique Protocol Identification Number

NCT00516113

Brief Title

A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria

Official Title

A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine When Used for the Treatment of Premenstrual Dysphoria

Study Type

Interventional

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Completed

Study Start Date

October 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Karolinska Institutet

Collaborators

Novo Nordisk A/S, GlaxoSmithKline, Göteborg University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this study is to explore the onset of action when serotonin reuptake inhibitors are used to treat premenstrual dysphoric disorder

Detailed Description

Whereas serotonin reuptake inhibitors (SRIs) usually require weeks of treatment to effectively counteract depressed mood or anxiety, several studies suggest that they may reduce the symptoms irritability and anger more rapidly. In line with this, SRIs have been shown to reduce certain symptoms, including irritability, in women with premenstrual dysphoric disorder (PMDD) when the drug only is administered from ovulation to menstruation only, which indicates an onset of action of 10 days or less. How fast this effect appears in terms of hours or days is, however, not known. The objective of this study was to explore this issue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premenstrual Dysphoric Disorder, Premenstrual Syndrome

Keywords

paroxetine, onset of action, serotonin reuptake inhibitors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Paroxetine 20mg during the luteal phase of the menstrual cycle

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo during the luteal phase of the menstrual cycle

Intervention Type

Drug

Intervention Name(s)

paroxetine

Intervention Description

Capsules containing either placebo or paroxetine 20 mg. The treatment start after ovulation and when the subject has experienced premenstrual irritability for 2 days. The dosage is one capsule daily at 8 AM

Primary Outcome Measure Information:

Title

The number of patients reaching sustained remission (irritability) for each time point

Secondary Outcome Measure Information:

Title

Self rated irritability at each time point

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient should have participated in an ongoing placebo-controlled trial regarding the effect of paroxetine in PMD; to be included in that trial, she must have fulfilled the diagnostic criteria A-C of PMDD in DSM-IV and certain other inclusion and exclusion criteria which are listed in appendix 1. The patient should a) have been given paroxetine during the previous trial, b) have reported that she has been "much improved" or "very much improved" by this treatment, c) have displayed a marked reduction in VAS-rated irritability during treatment, and d) have reported that she has found the side-effects tolerable. The patient should display at least a 50% increase in VAS-rated irritability during the luteal phase (mean of last five days prior to menses) as compared the follicular phase (days 6-10) during one cycle of pretreatment symptom rating (without medication). The patient should have given written informed consent to participate in the study. Exclusion Criteria: Any concomitant psychiatric disorder for which SRIs are known to be effective. Any other concomitant psychiatric disorder that, in the investigator's opinion, would render the patient unsuitable for the study. Any somatic disorder that, in the investigator's opinion, would render the patient unsuitable for the study. Any ongoing medication which, in the opinion of the investigator, would render the patient unsuitable for the study. Examples of medications that preclude participation in the study are: 1) any psychotropic drug, with the exception of the occasional use of hypnotics, 2) any hormonal preparation, with the exception of thyroid hormone, 3) anti-coagulants, and 4) 5HT1D agonists. Occasional use of analgesic compounds does not preclude participation. Patient characteristics which, in the opinion of the investigator, are likely to reduce compliance with the protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mikael SG Landen, MD, PhD

Organizational Affiliation

Karolinska Institutet, Stockholm, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Psychiatric clinic, Sahlgrenska University Hospital

City

Göteborg

ZIP/Postal Code

SE43180

Country

Sweden

12. IPD Sharing Statement

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A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria

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