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

This study has been completed.
Sponsor:
Collaborators:
Novo Nordisk A/S
GlaxoSmithKline
Göteborg University
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00516113
First received: August 13, 2007
Last updated: December 6, 2007
Last verified: August 2007
  Purpose

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


Condition Intervention Phase
Premenstrual Dysphoric Disorder
Premenstrual Syndrome
Drug: paroxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine When Used for the Treatment of Premenstrual Dysphoria

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

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

Enrollment: 24
Study Start Date: October 2000
Study Completion Date: November 2002
Arms Assigned Interventions
Active Comparator: 1
Paroxetine 20mg during the luteal phase of the menstrual cycle
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
Placebo Comparator: 2
Placebo during the luteal phase of the menstrual cycle
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516113

Locations
Sweden
The Psychiatric clinic, Sahlgrenska University Hospital
Göteborg, Sweden, SE43180
Sponsors and Collaborators
Karolinska Institutet
Novo Nordisk A/S
GlaxoSmithKline
Göteborg University
Investigators
Principal Investigator: Mikael SG Landen, MD, PhD Karolinska Institutet, Stockholm, Sweden
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00516113     History of Changes
Other Study ID Numbers: L&E-5
Study First Received: August 13, 2007
Last Updated: December 6, 2007
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
paroxetine
onset of action
serotonin reuptake inhibitors

Additional relevant MeSH terms:
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Paroxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014