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

NCT03900754 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: MHBB-011-18F19-272651I01CX001761-01A2
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Schizophrenia

Keywords

Oxytocin

Outcome Measures

Primary Outcomes (1)

• Social Functioning Score

  The Social Functioning Scale is a 79-item semi-structured interview based assessment that includes \[a global summary score (primary outcome)\] The subscale scores of social engagement, interpersonal communication, and prosocial were expected the change in 3 weeks, while other subscales were not expected to change (e.g. employment) and thus were not collected during the chronic period. Scale ranges from 0 to lower functioning to 90 higher functioning.

  Baseline visit: Full assessment is collected prior to any treatments fMRI phase: assessment not collected Chronic phase: partial assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration

Secondary Outcomes (1)

• CAINS Score (Clinical Assessment Interview for Negative Symptoms)

  Baseline visit: assessment is collected prior to any treatments fMRI phase: assessment not collected Chronic phase: assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration

Other Outcomes (2)

• QLS Scale (Quality of Life)

  Baseline visit: assessment not collected fMRI phase: assessment not collected Chronic phase: assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration

• Hinting Task

  Baseline visit: assessment not collected fMRI phase: assessment not collected Chronic phase: assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration

Study Arms (2)

Intranasal Oxytocin

EXPERIMENTAL

Dosages of oxytocin: 20IU or 40IU.

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Saline

Drug: Placebo

Interventions

Oxytocin DRUG

Intranasal administration of oxytocin

Also known as: Syntocinon

Intranasal Oxytocin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of California, San Francisco: collaborator
• VA Greater Los Angeles Healthcare System: collaborator

Study Sites (2)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Study did not reach target enrollment numbers needed to achieve target power and statistically reliable results

Results Point of Contact

• Title: Dr. Josh Woolley
• Organization: San Francisco VA Medical Center

joshua.woolley@va.gov

415-221-4810

Study Officials

• Josh Woolley, BS

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model 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. 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.

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: January 13, 2020
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: January 20, 2026
• Results First Posted: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)