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

Premenstrual Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516113
• Other study ID #: L&E-5
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2007
• Last updated: December 6, 2007
• Start date: October 2000
• Est. completion date: November 2002

Study information

• Verified date: August 2007
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premenstrual Dysphoric Disorder
• Premenstrual Syndrome

Intervention

Drug:
• paroxetine
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

Locations

Country	Name	City	State
Sweden	The Psychiatric clinic, Sahlgrenska University Hospital	Göteborg

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	GlaxoSmithKline, Göteborg University, Novo Nordisk A/S

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients reaching sustained remission (irritability) for each time point
Secondary	Self rated irritability at each time point