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Clinical trial

Effects of Oxytocin on Social Cognition Training: Relationship to Target Engagement

ID
Name
OT R33
Description
This study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program.
Trial arms
Trial start
2018-01-04
Estimated PCD
2024-07-31
Trial end
2024-07-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Oxytocin nasal spray
nasal spray
Arms:
Oxytocin with Health Management, Oxytocin with SCST
Other names:
OT
Social Cognition Skills Training
Group based training in social cognition skills
Arms:
Oxytocin with SCST, Placebo with SCST
Other names:
SCST
Health Management
Group-based training in mental health management
Arms:
Oxytocin with Health Management, Placebo with HM
Other names:
HM
Placebo nasal spray
placebo condition
Arms:
Placebo with HM, Placebo with SCST
Other names:
PBO
Size
120
Primary endpoint
Social Cognition Composite Score
16 weeks
Eligibility criteria
Inclusion Criteria: * Schizophrenia or schizoaffective disorder * stable on an antipsychotic medication Exclusion Criteria: * positive pregnancy test history of head injury
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double-Blind Placebo controlled', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2024-03-15

1 organization

2 products

1 indication

Organization
University of California, Los Angeles
Product
Oxytocin
Indication
Schizophrenia
Product
Placebo