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

Not Applicable

• Conditions: F41.2; F31; F32; F33; Mixed anxiety and depressive disorder; Bipolar affective disorder; Depressive episode; Recurrent depressive disorder

• Registration Number: DRKS00017653
• Lead Sponsor: Klinikum rechts der Isar der TU München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-09-17
• Study Start: 2019-08-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 51

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

Not able to give written consent. Suicidiality.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.