Summary

for people ages 18-65 (full criteria)
at San Francisco, California
study started
estimated completion
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. 75 participants will be randomized to receive 20IU oxytocin and placebo and 75 will be randomized to receive 40IU oxytocin and placebo, with the order of administration randomized and separated by two weeks. 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 (55 from each cohort of 75) 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

SchizophreniaOxytocinIntranasal Oxytocin

Eligibility

You can join if…

Open to people ages 18-65

  • Veteran
  • age 18-65
  • a diagnosis of schizophrenia determined by the Structured Clinical Interview for DSM-V
  • no medication changes or psychiatric hospitalizations in the past month
  • SFS raw score of no more than 115
  • CAINS Motivation and Pleasure subscale score of at least 18
  • CAINS Experience subscale score of at least 8.

You CAN'T join if...

  • substance use disorder in the past month
  • 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 or 5HT1a agonists/antagonists
  • inability to complete VOT

Location

  • San Francisco VA Medical Center, San Francisco, CA not yet accepting patients
    San FranciscoCalifornia94121United States

Lead Scientist

  • Josh Woolley
    Dr. Woolley has been studying the underpinnings of social deficits in schizophrenia and has examined how oxytocin might be a useful treatment for these social deficits. People with schizophrenia often have functionally significant social cognitive deficits, and there are currently no available pharmacological treatments that target these deficits.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT03900754
Phase
Phase 2
Study Type
Interventional
Last Updated