F20 F21 F23 F25 F32 F33
Conditions
Interventions
Group 1: patients with schizophrenia spectrum disorder:
All visits are the same over all groups.
Study duration: 24 weeks
• Visit 1: Mini-DIPS Neuropsychiatric Interview, clinical scales, neuropsycho
Sponsors
Zentralinstitut für Seelische Gesundheit
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. 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) 3) Quantification of patient adherence to longitudinal daily life assessments within and across diagnostic groups | — |
Countries
Germany
Contacts
Public ContactAnastasia Benedyk
Zentralinstitut für Seelische Gesundheit
Outcome results
None listed