A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

Schizophrenia has a devastating and disproportionate effect on veterans compared to the general US population. Some of the most disabling symptoms, such as low motivation, difficulty expressing emotions, and decreased ability to infer the mental states of others, cause poor social functioning. This means that veterans with schizophrenia have trouble navigating interpersonal interactions and building meaningful relationships in the community. Unfortunately, current antipsychotic medications typically only improve positive symptoms but fail to improve social functioning deficits, which are strong predictors of poor quality of life and functional outcomes. Oxytocin, a peptide found in the brain, plays an important role in social behavior and is known to moderate affiliation, stress, and learning across taxa. In this study, the investigators will test whether oxytocin could be an effective treatment for social functioning deficits in schizophrenia. The investigators will examine changes in brain activation to understand how oxytocin affects behavior and to predict which individuals may benefit from oxytocin treatment.

Key facts

Study ID

NCT03900754

Run by

VA Office of Research and Development

People needed

26

Starts

2020-01-13

Expected to finish

2024-01-31

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Veteran
• age 18-70
• a diagnosis of schizophrenia, schizophreniform, schizoaffective, or brief psychotic disorder determined by the Structured Clinical Interview for DSM-5
• no medication changes or psychiatric hospitalizations in the past month
• SFS modified raw score of no more than 75

You may not qualify if…

• substance use disorder in the past month, except mild to moderate cannabis use disorder
• illness affecting the nasal passages
• significant neurological/medical disorder
• pacemakers
• extensive dental work
• claustrophobia
• deafness
• inability to read
• currently participating in a psychosocial intervention targeting social functioning deficits
• currently taking high dose testosterone or estrogen/progesterone
• inability to complete VOT

Where it is running

• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles, California, United States

Full record on ClinicalTrials.gov

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