Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Josh Woolley, BS
Headshot of Josh Woolley
Josh Woolley

Description

Summary

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.

Details

The study uses a combined within- and between-subject placebo-controlled study design. After screening, participants will be randomized into two study arms for the fMRI phase of the study. In each study arm, participants will complete a placebo-controlled, within-subject, pharmaco-fMRI paradigm with one of two possible dosages of oxytocin (20 or 40IU) and placebo. In the fMRI scanner, they will complete two well-validated theory of mind tasks: the false belief task and the person description task. Following the fMRI phase of the study, participants will be randomized to receive the same dosage of oxytocin the participant received in the fMRI phase, or placebo, twice daily for 3 weeks. Before and after the three weeks of drug administration, participants will be assessed for social functioning, social ability, negative symptoms, and theory of mind. More participants will be randomized to receive chronically administered oxytocin than placebo to maximize the study's power to test the investigators' hypothesis that acute oxytocin-induced increases in right temporo-parietal junction activity will be positively correlated with improvements in social functioning (primary outcome), social ability, negative symptoms, and theory of mind over three weeks of oxytocin administration.

Keywords

Schizophrenia, Oxytocin, Intranasal Oxytocin

Eligibility

You can join if…

Open to people ages 18-70

  • 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 CAN'T join 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

Locations

  • San Francisco VA Medical Center, San Francisco, CA
    San Francisco California 94121-1563 United States
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
    West Los Angeles California 90073 United States

Lead Scientist at UCSF

  • Josh Woolley, BS
    Dr. Josh Woolley is an Associate Professor in Residence in the Department of Psychiatry and Behavioral Sciences at the University of California, San Francisco (UCSF) as well as a staff psychiatrist in Mental Health at the San Francisco Veterans Affairs Medical Center (SFVAMC). He is Board Certified in Psychiatry by the American Board of Psychiatry and Neurology.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT03900754
Phase
Phase 2 Schizophrenia Research Study
Study Type
Interventional
Participants
About 26 people participating
Last Updated