IN Depth multimodal Characterization of negative symptoms

Recruiting

• Conditions: F20; F21; F23; F25; F32; F33; Schizophrenia; Schizotypal disorder; Acute and transient psychotic disorders; Schizoaffective disorders

• Registration Number: DRKS00020581
• Lead Sponsor: Zentralinstitut für Seelische Gesundheit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Sufficient level of german language; Ability to understand the study protocol and to give an informed consent; Will to use the device for ambulatory assessment

Exclusion Criteria

Chronic endocrinologic, cardiovascular, immunologic, and clinically manifest mental disorders; Current alcohol or drug dependence.

Additional for healthy individuals:
Acute or mental illness

Additional for MRI exams:
Pregnancy; Metal parts in the body; Cotraindicative abnormalities in medical history;
Claustrophobia

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes between baseline and follow-up visits after 12 and 24 weeks in the mean negative symptom factor score of the Positive and Negative Syndrome Scale (PANSS) and depressive symptom load (MADRS) within and across diagnostic groups.

Secondary Outcome Measures

Name	Time	Method
1) Changes between baseline and follow-up visits after 6, 12, 18 and 24 weeks in the mean negative symptom factor score of the Self-report of negative symptom (SNS) load within and across diagnostic groups.<br>2) Changes between baseline and follow-up visits after 12 and 24 weeks in the functional disease outcomes including cognition (CSB), social and occupational functioning (WHODAS 2.0, PSP) and quality of life (WHOQOL-Bref)<br>3) Quantification of patient adherence to longitudinal daily life assessments within and across diagnostic groups