NCT01200615

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2010

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

September 13, 2010

Status Verified

September 1, 2010

Enrollment Period

2 years

First QC Date

August 26, 2010

Last Update Submit

September 10, 2010

Conditions

Depression

Keywords

nocebo side-effects SSRI informed consent

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Explanation about common side effects

OTHER

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.

Explaning side effects and the nocebo effect

OTHER

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.

explanation about the nocebo effect

OTHER

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.

Interventions

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

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

Explanation about common side effectsExplaning side effects and the nocebo effectexplanation about the nocebo effect

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-60
  • started on an SSRI

You may not qualify if:

  • Psychotic spectrum disorder
  • Suicidality
  • Sensitivity to SSRI
  • Has taken the prescribed SSRI in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalvata Mental Health Center

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Uri Nitzan, MD

    Shalvata Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2010

First Posted

September 13, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2013

Last Updated

September 13, 2010

Record last verified: 2010-09

Locations

IL(1)