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

NCT00516113 | Completed Phase 4

• 1 other identifier: L&E-5
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Premenstrual Dysphoric Disorder; Premenstrual Syndrome

Keywords

paroxetine; onset of action; serotonin reuptake inhibitors

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Self rated irritability at each time point

Study Arms (2)

1

ACTIVE COMPARATOR

Paroxetine 20mg during the luteal phase of the menstrual cycle

Drug: paroxetine

2

PLACEBO COMPARATOR

Placebo during the luteal phase of the menstrual cycle

Drug: paroxetine

Interventions

paroxetine DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Novo Nordisk A/S: collaborator
• GlaxoSmithKline: collaborator
• Göteborg University: collaborator

Study Sites (1)

The Psychiatric clinic, Sahlgrenska University Hospital

Gothenburg, SE43180, Sweden

Location

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder; Premenstrual Syndrome

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mikael SG Landen, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 13, 2007
• First Posted: August 14, 2007
• Study Start: October 1, 2000
• Study Completion: November 1, 2002
• Last Updated: December 7, 2007

Record last verified: 2007-08

Locations

SE (1)