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Completed

NCT Number: NCT02567032

Adult Study Oxytocin - Behavioral

In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia and other psychotic disorders. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia and other psychotic disorders.

Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia.

Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo.

Hypothesis B: Patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

San Francisco Veterans Affairs Medical Center, San Francisco, California, United States

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About this study

Part 2: A supplementary study will be added to the proposed parent study, which includes additional behavioral testing consisting of several social cognition computer tasks, clinical assessments, physiological measurements, and questionnaires. The study will be conducted with the same study arms and study interventions as in the proposed parent study. For this supplementary study, the inclusion criteria has broadened to include patients with bipolar disorder with psychotic features and brief psychotic disorder.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Patients:

  • 18 to 45 years of age
  • Clinically stable
  • English Speaking
  • Meet DSM-5 criteria for schizophrenia, schizophreniform, schizoaffective disorder, bipolar disorder with psychotic features, or brief psychotic disorder
  • No or at most only minor changes to medications in the past week
  • Able to use nasal spray
  • Must be capable of providing informed consent

Inclusion criteria

for healthy volunteers:

  • 18 to 45 years of age
  • Clinically stable
  • English Speaking
  • No diagnosis of mental disorder according to DSM-5, not including mild alcohol use disorder or mild cannabis use disorder
  • Able to use nasal spray
  • Must be capable of providing informed consent

Exclusion criteria

for Patients:

  • Active substance and alcohol use disorder in the past month as determined by the DSM-5 criteria, not including cannabis use disorder
  • Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)
  • Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator
  • Hearing deficits
  • Pregnancy
  • Severe brain trauma

Exclusion criteria

for Healthy Controls:

  • Active substance and moderate/severe alcohol use disorder, or mood disorder in the past month as determined by the DSM-5 criteria, not including mild alcohol use disorder or mild cannabis use disorder
  • Meet for a current psychiatric disorder according to DSM-5 criteria
  • Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)
  • Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator
  • Hearing deficits
  • Pregnancy
  • Severe brain trauma

Treatment and study plan

Oxytocin

Drug

40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.

Other names: Syntocinon

Saline Nasal Spray

Drug

40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Other names: Placebo

Primary outcomes

  1. Change in Social Cognition Task Performance

    Time frame: Through study completion, 2-3 weeks

    Participants will undergo computer tasks that measure social cognition. Tasks will involve verbal responses, pressing buttons at specific times, listening, and viewing audio-visual stimuli. Investigators will be measuring the difference in accuracy and verbal content of the responses on the oxytocin day compared to the placebo day.

Secondary outcomes

  1. Physiological Measurements

    Time frame: Through study completion, 2-3 weeks

    Sensors will be attached to measure heart rate, respiration, and skin conductance during computer tasks.

  2. Questionnaire

    Time frame: At baseline visit, up to 4 hours

    Participants will be asked questions about their current positive and negative symptoms, medical and psychiatric history. Self-report responses will be saved in writing or audio recording.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • San Francisco Veterans Affairs Medical Center

Registry information

Official study title

Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - Behavioral

Acronym: ASO-Behavioral

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2015
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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