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Nocebo effects by providing informed consent in shared decision making? Not necessarily: A randomized pilot-trial.

Nocebo effects by providing informed consent in shared decision making? Not necessarily: A randomized pilot-trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017653
Enrollment
60
Registered
2019-08-30
Start date
2013-12-02
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F41.2 F31 F32 F33

Interventions

Group 1: For one night, patients receive an open-Label Placebo pill instead of their usual sleep medication. A detailed Information about effects and side effects in Terms of "informed consent" is per

Sponsors

Klinikum rechts der Isar der TU München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Diagnosis of a depressive disorder (ICD-10: F31, F32, F33 oder F41). Documented sleep disorder. Sleep medication. Inpatient Treatment for at least 7 days.

Exclusion criteria

Exclusion criteria: Not able to give written consent. Suicidiality.

Design outcomes

Primary

MeasureTime frame
Primary outcome is the amount of impairment by side effects through the new medication indicated on a visual analogue scale. Values vary from 1 (not at all) to 10 (a lot). The Rating takes place in the morning after the Placebo Administration.

Secondary

MeasureTime frame
Subjective Quality of Sleep. The rating takes place in the morning after the placebo administration using an in-house questionnaire that is routinely used in the somnological department of our clinic.

Countries

Germany

Contacts

Public ContactFabian Holzhüter

Klinik und Poliklinik für Psychiatrie und Psychotherapie des Klinikums rechts der Isar der TU München

fabian.holzhueter@mri.tum.de089/41404267

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026