Last updated: 11/07/2018 14:11:26
A Double-Blind, Placebo-Controlled, Three-Arm Fixed-Dose Study of Paroxetine CR Continuous Treatment (12.5 mg/day and 25 mg/day) for Premenstrual Dysphoric Disorder
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Double-Blind, Placebo-Controlled, Three-Arm Fixed-Dose Study of Paroxetine CR Continuous Treatment (12.5 mg/day and 25 mg/day) for Premenstrual Dysphoric Disorder
Trial description: A Double-Blind, Placebo-Controlled, Three-Arm Fixed-Dose Study of Paroxetine CR Continuous Treatment (12.5 mg/day and 25 mg/day) for Premenstrual Dysphoric Disorder
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Cohen LS, Soares CN, Yonkers KA, et al. Paroxetine Controlled Release for Premenstrual Dysphoric Disorder: a double-blind, placebo controlled trial. Psychosomatic Medicine 2004; 66: 707-713
Paroxetine controlled - release (cr) is effective in the treatment of premenstrual dysphoric disorder (pmdd): results from a randomized placebo controlled trial. T.B.Pearlstein', K.M.Bellew 2, J.EndiCott3 , F.J.Holland , and M. Steiner 41st Annual Meeting of the American College of Neuropsychopharmacology 12/8/2002 San Juan; Puerto Rico
Paroxetine controlled release for premenstrual dysphoric disorder: remission analysis following a randomized, double-blind, placebo-controlled trial. Pearlstein, T. B., Bellew, K. M., Endicott, J., and Steiner, M. Prim Care Companion J Clin Psychiatry 2005; 7(2):53-60
Paroxetine controlled release is effective in treating premenstrual dysphoric disorder. Cohen, Lee S. MD, Soares, Claudio N. MD, Yonkers, Kimberly A. MD, Bellew, Kevin M. MS, Bridges, Ian M. MSc, and Heller, Vicki L. MD 51st Annual Clinical Meeting of the American College of Obstetricians and Gynecologists 4/26/2003 New Orleans, LA; USA
Paroxetine controlled-release (cr) is effective in treating mood and anxiety symptoms associated with premenstrual dysphoric disorder (pmdd). Kevin M. Bellew, M. S. 23rd Annual Conference of the Anxiety Disorders Association of America 3/27/2003 Toronto, ON; Canada
Medical condition
Premenstrual Syndrome
Product
paroxetine
Collaborators
Not applicable
Study date(s)
November 1999 to January 2002
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-22-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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