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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

August 13, 2007
December 6, 2007
October 2000
Not Provided
The number of patients reaching sustained remission (irritability) for each time point
Same as current
Complete list of historical versions of study NCT00516113 on ClinicalTrials.gov Archive Site
Self rated irritability at each time point
Same as current
Not Provided
Not Provided
 
A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria
A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine When Used for the Treatment of Premenstrual Dysphoria

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Premenstrual Dysphoric Disorder
  • Premenstrual Syndrome
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
  • Active Comparator: 1
    Paroxetine 20mg during the luteal phase of the menstrual cycle
    Intervention: Drug: paroxetine
  • Placebo Comparator: 2
    Placebo during the luteal phase of the menstrual cycle
    Intervention: Drug: paroxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2002
Not Provided

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00516113
L&E-5
No
Not Provided
Karolinska Institutet
  • Novo Nordisk A/S
  • GlaxoSmithKline
  • Göteborg University
Principal Investigator: Mikael SG Landen, MD, PhD Karolinska Institutet, Stockholm, Sweden
Karolinska Institutet
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP