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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00516113
Other study ID # L&E-5
Secondary ID
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
Est. primary completion date
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


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
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