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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01200615
• Other study ID #: 025622648
• Status: Not yet recruiting
• Phase: N/A
• First received: August 26, 2010
• Last updated: September 10, 2010
• Start date: October 2010
• Est. completion date: October 2013

Study information

• Verified date: September 2010
• Source: Shalvata Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 66 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression

Intervention

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.

Locations

Country	Name	City	State
Israel	Shalvata Mental Health Center	Hod Hasharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of side-effects	We are interested in the possible influence of the physicians wording upon recieving informed consend from the patient and the prevalence of side-effects	6 weeks	Yes