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The Nocebo Effect: a Prospective Study of Informed Consent as a Factor in the Prevalence of SSRI's Side Effects

This study is not yet open for participant recruitment.
Verified September 2010 by Shalvata Mental Health Center
Sponsor:
Information provided by:
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01200615
First received: August 26, 2010
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  Purpose

In this study we invetigate the influence of the nocebo effect (as part of obtaining informed consent) on the prevalence of side-effects. The study is prospective, focusing on the connection between what the physicians says to the patient about side-effects to the frequency of these side effects during treatment period. We also inquire whether informing the patient about the existence of the nocebo effect influences the extent of phenomena.


Condition Intervention
Depression
 Behavioral: Wording of the explenation on side-effects as part of the informed consent.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Nocebo Effect: a Prospective Study of Informed Consent as a Factor in the Prevalence of SSRI's Side Effects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • The prevalence of side-effects [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    We are interested in the possible influence of the physicians wording upon recieving informed consend from the patient and the prevalence of side-effects


Estimated Enrollment: 150
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Explanation about common side effects
50 patients started on SSRI's will be updated about its common side effects
 Behavioral: Wording of the explenation on side-effects as part of the informed consent.
Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.
Explaning side effects and the nocebo effect
subjects started on SSRI's will be updated about its common side effects and the nocebo effect
 Behavioral: Wording of the explenation on side-effects as part of the informed consent.
Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.
explanation about the nocebo effect
3. 50 patients started on SSRI's will receive an explenation on the nocebo effect, but will not be updated about common side-effects. Nonetheless, they will be informed of severe side-effects.
 Behavioral: Wording of the explenation on side-effects as part of the informed consent.
Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.

Detailed Description:

In this study the investigators wish to inquire whether the nature of the explenation given to the patient as part of informed consent has an effect on the prevalence of side-effects. The study will take place in the out-patient clinic at the Shalvata Mental health Center. Three arms are included:

  1. 50 patients started on SSRI's will be updated about its common side effects
  2. 50 patients started on SSRI's will be updated about its common side effects and will receive an explenation on the nocebo effect
  3. 50 patients started on SSRI's will receive an explenation on the nocebo effect, but will not be updated about common side-effects. Nonetheless, they will be informed of severe side-effects.

Following the prescription of an SSRI the subjects will we enter the follow-up phase of the study. They will attend two follow-up meetings: 3 days after the initiation point and one month after the starting point. During each meeting they will be asked to fill the Antidepressant Side-Effect Checklist (ASEC)and the General Health Questionnaire (GHQ).

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 18-60
  2. started on an SSRI

Exclusion Criteria:

  • Psychotic spectrum disorder
  • Suicidality
  • Sensitivity to SSRI
  • Has taken the prescribed SSRI in the past
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200615

Locations
Israel
Shalvata Mental Health Center
Hod Hasharon, Israel
Sponsors and Collaborators
Shalvata Mental Health Center
Investigators
Principal Investigator: Uri Nitzan, MD Shalvata Mental Health Center
  More Information

No publications provided

Responsible Party: Dr. Uri Nitzan, Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01200615     History of Changes
Other Study ID Numbers: 025622648
Study First Received: August 26, 2010
Last Updated: September 10, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Shalvata Mental Health Center:
nocebo side-effects SSRI informed consent

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013