DepressionNCT01200615
The Nocebo Effect: a Prospective Study of Informed Consent as a Factor in the Prevalence of SSRI's Side Effects
A study testing Wording of the explenation on side-effects as part of the informed consent. in people with Depression, run by Shalvata Mental Health Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Depression
- What is being tested?
- Wording of the explenation on side-effects as part of the informed consent.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-60
- started on an SSRI
Who cannot join
- Psychotic spectrum disorder
- Suicidality
- Sensitivity to SSRI
- Has taken the prescribed SSRI in the past
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 50 patients started on SSRI's will be updated about its common side effects
- 50 patients started on SSRI's will be updated about its common side effects and will receive an explenation on the nocebo effect
- 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
- Depression
- Being tested
- Wording of the explenation on side-effects as part of the informed consent.
- Keywords
- nocebo side-effects SSRI informed consent
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wording of the explenation on side-effects as part of the informed consent.Behavioural
Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.
| Study group | Role | What they receive |
|---|---|---|
| Explanation about common side effects | Other | 50 patients started on SSRI's will be updated about its common side effects Receives: 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 Receives: 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. Receives: Behavioral: Wording of the explenation on side-effects as part of the informed consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Investigators
- Uri Nitzan, MD, Principal investigator, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200615
- Sponsor's protocol ID
- 025622648
- Status last verified
- Sep 2010
- First submitted
- 26 Aug 2010
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nocebo Effect: a Prospective Study of Informed Consent as a Factor in the Prevalence of SSRI's Side Effects
- ClinicalTrials.gov ID
- NCT01200615
- Acronym / sponsor ID
- 025622648
- Conditions
- Depression
- Keywords
- nocebo side-effects SSRI informed consent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 50 patients started on SSRI's will be updated about its common side effects
- 50 patients started on SSRI's will be updated about its common side effects and will receive an explenation on the nocebo effect
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Explanation about common side effects | Other | Behavioral: Wording of the explenation on side-effects as part of the informed consent.50 patients started on SSRI's will be updated about its common side effects |
| Explaning side effects and the nocebo effect | Other | Behavioral: Wording of the explenation on side-effects as part of the informed consent.subjects started on SSRI's will be updated about its common side effects and the nocebo effect |
| explanation about the nocebo effect | Other | Behavioral: Wording of the explenation on side-effects as part of the informed consent.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. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18-60
- started on an SSRI
Key exclusion criteria (4 listed)
- Psychotic spectrum disorder
- Suicidality
- Sensitivity to SSRI
- Has taken the prescribed SSRI in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Explanation about common side effects, Explaning side effects and the nocebo effect, explanation about the nocebo effect |
Primary outcome
The prevalence of side-effects
Time frame: 6 weeks
We are interested in the possible influence of the physicians wording upon recieving informed consend from the patient and the prevalence of side-effects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uri Nitzan, MD principal investigator
Shalvata Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wording of the explenation on side-effects as part of the informed consent. in people with Depression, run by Shalvata Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of side-effects (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2010.