Status:
COMPLETED
OXYMIND: Oxytocin-augmented Group Psychotherapy for Patients With Schizophrenia
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Schizophrenia Spectrum Disorders
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The effectiveness of current treatment options for sociocognitive deficits and negative symptoms (NS) in schizophrenia spectrum disorders (SSD) remains limited. The cause of NS is thought to be an int...
Detailed Description
Schizophrenia spectrum disorders (SCZ) are severe mental illnesses with a lifetime prevalence of 1-2%. Three core syndromes characterize SCZ: positive and negative syndromes (NS), as well as a cogniti...
Eligibility Criteria
Inclusion
- declaration of consent
- Psychiatric diagnosis of schizophrenia (ICD-10: F2x.x spectrum) for group of patients
- Mild to moderate positive symptoms (5 ≤ Positive symptoms on individual items using P- PANSS)
- German should either be the native language or spoken at a native level.
- No change in systematically recorded psychopharmacological medication in the last 2 weeks before study inclusion.
Exclusion
- Acute psychotic episode with severe positive symptoms (ICD-10: F2 spectrum, 6 ≥ positive symptoms on individual items using P-PANSS).
- Acute suicidality
- Acute consumption phase of a substance dependence, except nicotine
- No severe physical impairments, neurological diseases and e.g. severe craniocerebral trauma e.g. early childhood brain damage
- Pregnancy and breastfeeding
- Current electroconvulsive therapy
- If one of the following criteria applies to the participants, we will conduct an individual consultation in advance to determine whether participation in the study is possible:
- Overweight or underweight (body mass index (BMI) \< 17.5 or \> 30)
- Disease of the endocrine system
- Impaired kidney or liver function
- Metabolic diseases
- Asthma
- Change in blood potassium or sodium levels
Key Trial Info
Start Date :
September 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06136390
Start Date
September 30 2023
End Date
December 30 2024
Last Update
December 1 2025
Active Locations (1)
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1
Charité Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, State of Berlin, Germany, 12203