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

NCT ID: NCT01200615

Last Updated: 2010-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Explanation about common side effects

50 patients started on SSRI's will be updated about its common side effects

Group Type OTHER

Wording of the explenation on side-effects as part of the informed consent.

Intervention Type BEHAVIORAL

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

Group Type OTHER

Wording of the explenation on side-effects as part of the informed consent.

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Wording of the explenation on side-effects as part of the informed consent.

Intervention Type BEHAVIORAL

Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shalvata Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Shalvata Mental Health Center

Principal Investigators

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Uri Nitzan, MD

Role: PRINCIPAL_INVESTIGATOR

Shalvata Mental Health Center

Locations

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Shalvata Mental Health Center

Hod HaSharon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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025622648

Identifier Type: -

Identifier Source: org_study_id