Premenstrual SyndromeNCT00965562

Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)

A study testing Fluoxetine and Calcium in people with Premenstrual Syndrome, run by Donaghue Medical Research Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 48 years, women only
Conditions the study is for: Premenstrual Syndrome
What is being tested?: Fluoxetine and Calcium
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 49 participants
Where: 1 siteUnited States
Study dates: Sep 2000to Oct 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 48 years
Women only
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale School of Medicine
New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: A Double-blind, Parallel Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)

Read the detailed description

This is a double blind, randomized, placebo controlled, parallel study that will randomize 60 women at the Yale site into treatment. Participants will be screened at various collaborating ob-gyn centers for possible PMS symptoms, and direct referrals from the community will also be accepted. Subject participation length is about 7 months with 6 scheduled study visits.

Methodology: After successfully completing the screening and qualification phase, participants will be randomized to treatment at Visit 1 for 5 cycles of double-blind treatment. Participants will be evaluated monthly during the randomization phase for adverse events, concurrent medication, and primary and secondary efficacy variables.

Conditions: Premenstrual Syndrome
Being tested: Fluoxetine, Calcium, Placebo
Keywords: Premenstrual syndrome, PMS, calcium
Medical subject headings: Premenstrual Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FluoxetineDrug
Also called Prozac
Fluoxetine 20 mg per day for 4 menstrual cycles. For the fifth menstrual cycle, all women will receive calcium. Women on Fluoxetine will continue taking it in addition to 1200mg of calcium.
CalciumDrug
1200 mg of calcium to be taken for 5 menstrual cycles.
PlaceboDrug
For 5 cycles, women will receive placebo. At the end of the fourth cycle, all women will receive 1200 mg of calcium in addition to the placebo medication.

Study groups in NCT00965562
Study group	Role	What they receive
I	Active comparator	Fluoxetine Receives: Drug: Fluoxetine
II	Active comparator	Calcium Receives: Drug: Calcium
III	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of the Change in IDS Symptom Scores Among Groups
IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Measured: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Comparison of the Change in PMTS Symptom Scores Among Groups
PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Measured: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Comparison of the Change in CGI-S Symptom Scores Among Groups
CGI-S = Clinical Global Impression-Severity: a severity scale widely used in psychopharmacology research (1=normal not at all ill, 7=among most extremely ill). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Measured: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Comparison of the Change in DRSP Symptom Scores Among Groups
DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Measured: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Comparison of the Change in CGI Improvement Scores Among Groups
CGI-I = Clinical Global Impression Improvement: the improvement subscale of CGI measuring change at each visit as compared to visit 1 (1=very much improved, 7=very much worse). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Measured: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit

Secondary outcomes (6)

Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)
DRSP: Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. LOCF: the last observation carried forward.
Measured: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)
IDS: Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=least severe, 84=most severe). LOCF: last observation carried forward.
Measured: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)
PMTS: Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). LOCF: last observation carried forward.
Measured: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement)
Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme.
Measured: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit
Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement)
Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit.
IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency, sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe).
Measured: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit
Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement)
Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe).
Measured: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2000Oct 2010

First posted25 Aug 2009 (estimated)
Study startSep 2000
Primary completionJun 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00965562
Sponsor's protocol ID: 0001011511
Status last verified: Feb 2015
First submitted: 24 Aug 2009
Last updated: 23 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Premenstrual Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Parallel Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
ClinicalTrials.gov ID: NCT00965562
Acronym / sponsor ID: 0001011511
Conditions: Premenstrual Syndrome
Keywords: Premenstrual syndrome, PMS, calcium
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Donaghue Medical Research FoundationUniversity, hospital or other
Collaborators: Yale University
Study start: Sep 2000
Primary completion: Jun 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 25 Aug 2009 (estimated)
Results: Posted 26 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
I	Active comparator	Drug: FluoxetineFluoxetine
II	Active comparator	Drug: CalciumCalcium
III	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 48 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Female outpatients between the ages of 18 and 48 who are:

Key exclusion criteria (8 listed)

Any candidate who:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FluoxetineAlso: ProzacFluoxetine 20 mg per day for 4 menstrual cycles. For the fifth menstrual cycle, all women will receive calcium. Women on Fluoxetine will continue taking it in addition to 1200mg of calcium.	Drug	I
Calcium1200 mg of calcium to be taken for 5 menstrual cycles.	Drug	II
PlaceboFor 5 cycles, women will receive placebo. At the end of the fourth cycle, all women will receive 1200 mg of calcium in addition to the placebo medication.	Drug	III

Primary outcome

Comparison of the Change in IDS Symptom Scores Among Groups
Time frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Comparison of the Change in PMTS Symptom Scores Among Groups
Time frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Comparison of the Change in CGI-S Symptom Scores Among Groups
Time frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
CGI-S = Clinical Global Impression-Severity: a severity scale widely used in psychopharmacology research (1=normal not at all ill, 7=among most extremely ill). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Comparison of the Change in DRSP Symptom Scores Among Groups
Time frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.
Comparison of the Change in CGI Improvement Scores Among Groups
Time frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
CGI-I = Clinical Global Impression Improvement: the improvement subscale of CGI measuring change at each visit as compared to visit 1 (1=very much improved, 7=very much worse). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.

6 secondary outcomes

Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)
Time frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)
Time frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)
Time frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement)
Time frame: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit
Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement)
Time frame: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit
Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement)
Time frame: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit

Results and safety

Results posted to the registry on 26 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
I: Fluoxetine	16	13
II: Calcium	17	13
III: Placebo	16	13

Primary outcome: Comparison of the Change in IDS Symptom Scores Among Groups

Time frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit. Mean (Standard Deviation). Unit: units on IDS scale

Measure	I: Fluoxetine n = 13	II: Calcium n = 13	III: Placebo n = 13
Visit 1	31.85 (9.14)	30.92 (7.62)	28.85 (9.97)
Visit 2	14.08 (9.53)	25.77 (7.74)	20.69 (12.20)
Visit 3	11.44 (7.94)	18.55 (10.40)	20.15 (14.25)
Visit 4	11.78 (8.50)	18.50 (9.01)	16.46 (11.00)
Visit 5	10.00 (6.41)	19.55 (9.04)	18.08 (9.17)

I: Fluoxetine vs III: Placebo: Slope: -2.63 (95% CI -5.51 to 0.24), p = 0.07, Mixed Models Analysis
II: Calcium vs III: Placebo: Slope: -0.10 (95% CI -2.85 to 2.65), p = 0.94, Mixed Models Analysis
I: Fluoxetine vs III: Placebo: Cohen's d effect size: 1.15, p = 0.07, Mixed Models Analysis

Population analysed: Intention to treat cohort.

Primary outcome: Comparison of the Change in PMTS Symptom Scores Among Groups

Time frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit. Mean (Standard Deviation). Unit: units on PMTS scale

Measure	I: Fluoxetine n = 13	II: Calcium n = 13	III: Placebo n = 13
Visit 1	24.15 (5.40)	21.58 (3.73)	20.85 (6.62)
Visit 2	11.15 (5.77)	18.54 (5.36)	16.00 (8.15)
Visit 3	10.33 (6.40)	13.36 (5.75)	16.38 (10.52)
Visit 4	12.11 (7.13)	12.83 (4.73)	12.77 (8.21)
Visit 5	10.13 (3.56)	11.91 (4.48)	14.58 (7.58)

I: Fluoxetine vs III: Placebo: Slope: -1.63 (95% CI -3.60 to 0.34), p = 0.10, Mixed Models Analysis
II: Calcium vs III: Placebo: Slope: -0.81 (95% CI -2.71 to 1.09), p = 0.40, Mixed Models Analysis
I: Fluoxetine vs III: Placebo: Cohen's d effect size: 1.06, p = 0.10, Mixed Models Analysis

Population analysed: Intention to treat cohort.

Primary outcome: Comparison of the Change in CGI-S Symptom Scores Among Groups

Time frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit. Mean (Standard Deviation). Unit: units on CGI-S scale

Measure	I: Fluoxetine n = 13	II: Calcium n = 13	III: Placebo n = 13
Visit 1	4.92 (0.95)	4.46 (1.27)	4.15 (1.28)
Visit 2	2.54 (1.13)	4.23 (1.01)	3.38 (1.66)
Visit 3	2.33 (1.00)	3.00 (1.10)	3.38 (1.98)
Visit 4	2.56 (1.13)	2.73 (0.90)	2.92 (1.50)
Visit 5	2.50 (0.76)	2.91 (1.04)	3.17 (1.47)

I: Fluoxetine vs III: Placebo: Slope: -0.35 (95% CI -0.73 to 0.03), p = 0.07, Mixed Models Analysis
II: Calcium vs III: Placebo: Slope: -0.17 (95% CI -0.54 to 0.20), p = 0.36, Mixed Models Analysis
I: Fluoxetine vs III: Placebo: Cohen's d effect size: 0.92, p = 0.07, Mixed Models Analysis

Population analysed: Intention to treat cohort.

Primary outcome: Comparison of the Change in DRSP Symptom Scores Among Groups

Time frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit. Mean (Standard Deviation). Unit: units on DRSP scale

Measure	I: Fluoxetine n = 13	II: Calcium n = 13	III: Placebo n = 13
Visit 1	2.16 (0.86)	1.12 (0.38)	1.29 (0.60)
Visit 2	0.97 (0.72)	0.76 (0.78)	0.93 (0.54)
Visit 3	0.27 (0.78)	0.61 (0.78)	1.19 (1.06)
Visit 4	0.72 (0.78)	0.51 (0.33)	0.59 (0.63)
Visit 5	0.44 (0.34)	0.75 (0.42)	0.74 (0.54)

I: Fluoxetine vs III: Placebo: Slope: -0.28 (95% CI -0.53 to -0.04), p = 0.02, Mixed Models Analysis
II: Calcium vs III: Placebo: Slope: 0.06 (95% CI -0.16 to 0.28), p = 0.58, Mixed Models Analysis
I: Fluoxetine vs III: Placebo: Cohen's d effect size: 2.08, p = 0.02, Mixed Models Analysis

Population analysed: Intention to treat cohort.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From patient randomization to completion of study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
I: Fluoxetine	0 of 10 (0%)	4 of 10 (40%)	Not reported
II: Calcium	0 of 11 (0%)	8 of 11 (72.7%)	Not reported
III: Placebo	0 of 11 (0%)	2 of 11 (18.2%)	Not reported

Limitations and caveats (from the sponsor): small sample size

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kimberly A Yonkers, MD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fluoxetine and Calcium in people with Premenstrual Syndrome, run by Donaghue Medical Research Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the Change in IDS Symptom Scores Among Groups (time frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00965562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2015.