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

Primary Purpose

Premenstrual Syndrome

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
P-Dragees rosa Lichtenstein
Sponsored by
Jens Gaab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring Premenstrual Syndrome, Open-Label Placebo Effect, randomized controlled trial

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate to severe PMS
  • Between 18 and 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

Sites / Locations

  • University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Treatment as Usual

Integrative Open-Label Placebo

Open-Label Placebo

Arm Description

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.

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 two dragées a day for six weeks. (Amendment regarding dosage since 08/18)

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 two dragées a day for six weeks. (Amendment regarding dosage since 08/18)

Outcomes

Primary Outcome Measures

PMS symptom intensity assessed by a PMS symptom diary sub sum score
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.
PMS symptom interference assessed by a PMS symptom diary sub sum score
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.

Secondary Outcome Measures

Experience of study participation in intervention groups
By means of semi-structured interviews, participants experience of participation in interventions groups of 10 women of the open-label placebo without treatment rationale group and of 10 women of the open-label placebo with treatment rationale group, who are randomly chosen out of the 50 participants of each of the intervention study groups will be assessed.

Full Information

First Posted
May 2, 2018
Last Updated
December 22, 2021
Sponsor
Jens Gaab
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1. Study Identification

Unique Protocol Identification Number
NCT03547661
Brief Title
Open-Label Placebo Treatment of Women With Premenstrual Syndrome
Acronym
OLPPMS_1
Official Title
Open-Label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
June 28, 2021 (Actual)
Study Completion Date
June 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Gaab

4. Oversight

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

5. Study Description

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. Furthermore, we assess participants experiences of study participation qualitatively by means of semi-structured interviews.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Premenstrual Syndrome, Open-Label Placebo Effect, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
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.
Arm Title
Integrative Open-Label Placebo
Arm Type
Active Comparator
Arm Description
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 two dragées a day for six weeks. (Amendment regarding dosage since 08/18)
Arm Title
Open-Label Placebo
Arm Type
Active Comparator
Arm Description
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 two dragées a day for six weeks. (Amendment regarding dosage since 08/18)
Intervention Type
Other
Intervention Name(s)
P-Dragees rosa Lichtenstein
Intervention Description
Placebo dragées
Primary Outcome Measure Information:
Title
PMS symptom intensity assessed by a PMS symptom diary sub sum score
Description
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.
Time Frame
Continuous measurement, starting from day 1 of the menstrual cycle (length of each cycle is on average 28 days) until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total)
Title
PMS symptom interference assessed by a PMS symptom diary sub sum score
Description
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.
Time Frame
Continuous measurement, starting from day 1 of the menstrual cycle (length of each cycle is on average 28 days) until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total)
Secondary Outcome Measure Information:
Title
Experience of study participation in intervention groups
Description
By means of semi-structured interviews, participants experience of participation in interventions groups of 10 women of the open-label placebo without treatment rationale group and of 10 women of the open-label placebo with treatment rationale group, who are randomly chosen out of the 50 participants of each of the intervention study groups will be assessed.
Time Frame
One time assessment, up to 2 years after baseline. The interview takes between 30 and 60 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate to severe PMS Between 18 and 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Gaab, Prof. Dr.
Organizational Affiliation
University of Basel, Faculty of Psychology, Division for Clinical Psychology and Psychotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Basel, Faculty of Psychology, Division of Clinical Psychology and Psychotherapy
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4055
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27755279
Citation
Carvalho C, Caetano JM, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I. Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain. 2016 Dec;157(12):2766-2772. doi: 10.1097/j.pain.0000000000000700. Erratum In: Pain. 2017 Feb;158(2):365.
Results Reference
background
PubMed Identifier
24401940
Citation
Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014 Jan 8;6(218):218ra5. doi: 10.1126/scitranslmed.3006175.
Results Reference
background
PubMed Identifier
21203519
Citation
Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.
Results Reference
background
PubMed Identifier
26352222
Citation
Maharaj S, Trevino K. A Comprehensive Review of Treatment Options for Premenstrual Syndrome and Premenstrual Dysphoric Disorder. J Psychiatr Pract. 2015 Sep;21(5):334-50. doi: 10.1097/PRA.0000000000000099.
Results Reference
background
Citation
O'Brien, P. S., Rapkin, A., & Schmidt, P. J. (2007). The premenstrual syndromes: PMS and PMDD: CRC Press.
Results Reference
background
PubMed Identifier
385093
Citation
Sampson GA. Premenstrual syndrome: a double-blind controlled trial of progesterone and placebo. Br J Psychiatry. 1979 Sep;135:209-15. doi: 10.1192/bjp.135.3.209.
Results Reference
background
PubMed Identifier
18171451
Citation
Sandler AD, Bodfish JW. Open-label use of placebos in the treatment of ADHD: a pilot study. Child Care Health Dev. 2008 Jan;34(1):104-10. doi: 10.1111/j.1365-2214.2007.00797.x.
Results Reference
background
PubMed Identifier
27744433
Citation
Schaefer M, Harke R, Denke C. Open-Label Placebos Improve Symptoms in Allergic Rhinitis: A Randomized Controlled Trial. Psychother Psychosom. 2016;85(6):373-374. doi: 10.1159/000447242. Epub 2016 Oct 15. No abstract available.
Results Reference
background
PubMed Identifier
16001107
Citation
Van Ree JM, Schagen Van Leeuwen JH, Koppeschaar HP, Te Velde ER. Unexpected placebo response in premenstrual dysphoric disorder: implication of endogenous opioids. Psychopharmacology (Berl). 2005 Oct;182(2):318-9. doi: 10.1007/s00213-005-0090-8. Epub 2005 Oct 19. No abstract available.
Results Reference
background
PubMed Identifier
18395582
Citation
Yonkers KA, O'Brien PM, Eriksson E. Premenstrual syndrome. Lancet. 2008 Apr 5;371(9619):1200-10. doi: 10.1016/S0140-6736(08)60527-9.
Results Reference
background
PubMed Identifier
32071176
Citation
Frey Nascimento A, Gaab J, Kirsch I, Kossowsky J, Meyer A, Locher C. Open-label placebo treatment of women with premenstrual syndrome: study protocol of a randomised controlled trial. BMJ Open. 2020 Feb 17;10(2):e032868. doi: 10.1136/bmjopen-2019-032868.
Results Reference
derived

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Open-Label Placebo Treatment of Women With Premenstrual Syndrome

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