ClinicalTrials.gov
ClinicalTrials.gov Menu

Open-Label Placebo Treatment of Women With Premenstrual Syndrome (OLPPMS_1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03547661
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Jens Gaab, University Hospital, Basel, Switzerland

Brief Summary:
This study aims to investigate the effect of an open-label placebo intervention on premenstrual syndrome (PMS) complaints. Women who suffer from moderate to severe PMS will be randomly allocated to three groups: to a treatment as usual group, an open-label placebo group, and an integrative open-label placebo group. Participants of all groups will conclude a prospective PMS screening for one menstrual cycle. Thereafter, participants of both intervention groups will obtain an openly administered placebo intervention for six weeks. Participants of the treatment as usual group will have the chance to obtain the same open-label placebo intervention after study conduct. Diverse measures will be assessed by means of a PMS symptom diary and questionnaires.

Condition or disease Intervention/treatment Phase
Premenstrual Syndrome Other: P-Dragees rosa Lichtenstein Not Applicable

Detailed Description:
Recent evidence suggests that in certain clinical conditions - such as chronic low-back pain, migraine, irritable bowel syndrome, attention deficit hyperactivity disorder, and rhinitis - placebos improve clinical outcomes even without deception. Premenstrual syndrome (PMS) is defined as clinically significant symptoms, comprising at least one emotional or physical symptom in the premenstrual phase of the menstrual cycle and which cause substantial distress or functional impairment . To date, there exists no study examining open-label placebo responses on PMS. However, PMS seems to be considerably susceptible to placebo effects: The Royal College of Obstetricians and Gynaecologists alerts to substantial placebo responses in randomized-controlled PMS trials and studies showed considerable placebo effects on PMS without any specific effect for the medication under examination. Furthermore, a myriad of distinctive therapies is described for PMS (including pharmacological and phytopharmaceutical drugs as well as complementary non-pharmacological interventions), yet partially mixed evidence is reported. Besides being considered as placebogenic, PMS symptoms are timely well-defined and delimited which further makes this condition attractive for an investigation of open-label placebo responses, as a possible amelioration can be measured in a delimited time frame. To sum up, a randomized controlled trial of an open-label placebo treatment of women with PMS allows to investigate ways to harness placebo effects ethically in clinical practice for syndromes with somatic and psychologically described characteristics.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Treatment as Usual
The treatment as usual (TAU) group will control for regression to the mean, spontaneous remission, natural course of disease, and the participants-provider interaction. Participants of the TAU group are allowed to continue their usual medication intake, given they are already on a stable dose (at least 30 days of intake) and the medication is not listed in the exclusion criteria.
Active Comparator: Integrative Open-Label Placebo

The intervention will encompass an integrative administration of "P-Dragees rosa Lichtenstein", which are pink placebo dragées without any active ingredient. Each dragée contents the following substances: lactose monohydrate; magnesium stearate (Ph. Eur.); microcrystalline cellulose; highly dispersed silicon dioxide; white clay, macrogol glycerolhydroxy stearate (Ph. Eur.); Arabic gum; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); erythrosine; aluminium salt (E 127); calcium carbonate; sucrose; glucose syrup; maize starch; macrogol 6000.

All participants will be informed that the administered dragées are placebo dragées and participants will be instructed to take one dragée a day for six weeks and during the premenstrual phase until three dragées per day if desired.

Other: P-Dragees rosa Lichtenstein
Placebo dragées

Active Comparator: Open-Label Placebo

The intervention will encompass an administration of "P-Dragees rosa Lichtenstein", which are pink placebo dragées without any active ingredient. Each dragée contents the following substances: lactose monohydrate; magnesium stearate (Ph. Eur.); microcrystalline cellulose; highly dispersed silicon dioxide; white clay, macrogol glycerolhydroxy stearate (Ph. Eur.); Arabic gum; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); erythrosine; aluminium salt (E 127); calcium carbonate; sucrose; glucose syrup; maize starch; macrogol 6000.

All participants will be informed that the administered dragées are placebo dragées and participants will be instructed to take one dragée a day for six weeks and during the premenstrual phase until three dragées per day if desired.

Other: P-Dragees rosa Lichtenstein
Placebo dragées




Primary Outcome Measures :
  1. PMS symptom severity assessed by a PMS symptom diary overall sum score [ Time Frame: Continuous measurement, starting from first day of the menstrual cycle (lenght of each cycle is counted as 28 days). until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total) ]
    Symptoms severity will be assessed by the overall sum score of a PMS symptom diary. PMS symptom intensity and interference will be rated by means of a six-level Likert scale, whereat 1 is the lowest rating and 6 the highest. The overall sum score of intensity and interference ratings enables the assessment of severity.

  2. PMS symptom intensity assessed by a PMS symptom diary sub sum score [ Time Frame: Continuous measurement, starting from day 1 of the menstrual cycle (lenght of each cycle is counted as 28 days) until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total) ]
    Symptom intensity will be assessed by an intensity sub scale of the PMS symptom diary. Intensity will be rated by means of a six-level Likert scale, whereat 1 is the lowest rating of symptom intensity and 6 the highest.

  3. PMS symptom interference assessed by a PMS symptom diary sub sum score [ Time Frame: Continuous measurement, starting from day 1 of the menstrual cycle (lenght of each cycle is counted as 28 days) until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total) ]
    Symptom interference will be assessed by an interference sub scale of the PMS symptom diary. Interference will be rated by means of a six-level Likert scale, whereat 1 is the lowest rating of interference and 6 the highest.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe PMS
  • Between 18 and below 45 years of age
  • A regular menstrual cycle, i.e., max. +/- 3 days of difference of cycle range
  • Menstrual cycle range not longer than 31 or shorter than 24 days
  • Participants have a general practioner or gynaecologist to consult
  • At least one premenstrual symptom causes the desire for a PMS treatment

Exclusion Criteria:

  • Brest feeding at the moment or during the last three months
  • Pregnancy
  • Failing menstruation onset in the course of two consecutive menstrual cycles
  • An essential mental or somatic disease
  • Drug or massive alcohol intake or of other psychoactive substances
  • Uptake of a new medication within the last 30 days
  • Menopause, premenopausal strain or amenorrhoea
  • Allergy of one of the ingredients of the placebo dragées (P-Dragees rosa Lichtenstein)
  • Women who are surgically sterilised, hysterectomised, or ovariectomised
  • BMI above 30
  • Actual or recent participation in psychotherapy due to premenstrual symptoms
  • Parallel participation in another study with investigational drugs or participation in another PMS study within the last three months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547661


Contacts
Contact: Antje Frey Nascimento, MSc +41 61 207 05 98 antje.freynascimento@unibas.ch
Contact: Cosima Locher, Dr. phil. +41 061 207 03 85 cosima.locher@unibas.ch

Locations
Switzerland
University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy Recruiting
Basel, Basel-Stadt, Switzerland, 4055
Contact: Antje Frey Nascimento, MSc         
Contact: Cosima Locher, Dr. phil.         
Principal Investigator: Jens Gaab, Prof. Dr.         
Sponsors and Collaborators
Jens Gaab
Investigators
Principal Investigator: Jens Gaab, Prof. Dr. University of Basel, Faculty of Psychology, Division for Clinical Psychology and Psychotherapy

Publications:
O'Brien, P. S., Rapkin, A., & Schmidt, P. J. (2007). The premenstrual syndromes: PMS and PMDD: CRC Press.

Responsible Party: Jens Gaab, Principal Investigator, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03547661     History of Changes
Other Study ID Numbers: ID 2017-02186
325130_170117 ( Other Grant/Funding Number: Swiss National Science Foundation )
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jens Gaab, University Hospital, Basel, Switzerland:
Premenstrual Syndrome
Open-Label Placebo Effect
randomized controlled trial

Additional relevant MeSH terms:
Syndrome
Premenstrual Syndrome
Disease
Pathologic Processes
Menstruation Disturbances
Calcium Carbonate
Titanium dioxide
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents
Photosensitizing Agents