N/A
N=49
Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
Premenstrual Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00965562 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Comparison of the Change in IDS Symptom Scores Among Groups — 31.85; 30.92; 28.85; 14.08 units on IDS scale — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fluoxetine (Drug); Calcium (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Donaghue Medical Research Foundation
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of the Change in IDS Symptom Scores Among Groups |
31.85; 30.92; 28.85; 14.08; 25.77; 20.69 | 0.07 |
| PRIMARY Comparison of the Change in PMTS Symptom Scores Among Groups |
24.15; 21.58; 20.85; 11.15; 18.54; 16.00 | 0.10 |
| PRIMARY Comparison of the Change in CGI-S Symptom Scores Among Groups |
4.92; 4.46; 4.15; 2.54; 4.23; 3.38 | 0.07 |
| PRIMARY Comparison of the Change in DRSP Symptom Scores Among Groups |
2.16; 1.12; 1.29; 0.97; 0.76; 0.93 | 0.02 sig |
| PRIMARY Comparison of the Change in CGI Improvement Scores Among Groups |
NA; NA; NA; 2.23; 3.46; 3.00 | 0.04 sig |
| SECONDARY Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement) |
0.80; 0.42; 0.42 | 0.15 |
| SECONDARY Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement) |
0.77; 0.31; 0.31 | 0.05 |
| SECONDARY Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement) |
0.62; 0.33; 0.16 | 0.06 |
| SECONDARY Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement) |
1.00; 0.50; 0.33 | 0.09 |
| SECONDARY Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement) |
1.00; 0.36; 0.33 | 0.005 sig |
| SECONDARY Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement) |
0.75; 0.36; 0.17 | 0.04 sig |
Summary
The purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in the treatment of moderate to severe PMS. Second, to compare each active agent to a placebo control. Third, to evaluate the efficacy of each treatment for specific symptom clusters (i.e. affective and somatic). Fourth, to determine whether the addition of calcium to on going fluoxetine treatment leads to additional therapeutic benefit.
Eligibility Criteria
Inclusion Criteria
- Female outpatients between the ages of 18 and 48 who are:
- Menstruating
- Meet criteria for moderate to severe PMS
- Report PMS symptoms for at least 9 our of the 12 months prior to screening; 4) *Are using an adequate method of birth control.
Exclusion Criteria
- Any candidate who:
- Fulfills MINI (DSM-IV) criteria for a serious AXIS 1 disorder
- Fulfills DSM-IV criteria during the charting phase consistent with a diagnosis of psychotic disorder, bipolar disorder or major depressive disorder
- Has a severe, co-existing condition that, in the investigator's opinion, renders the patient unsuitable for the study
- Poses a significant risk of suicide
- Takes ongoing medication that could treat PMS symptoms
- Has a history of hypersensitivity or adverse reaction to fluoxetine or calcium
- Is lactating, pregnant or is planning to become pregnant during the course of the study.
Data sourced from ClinicalTrials.gov (NCT00965562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.