Adult Study Oxytocin - Behavioral

NCT02567032 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 10-02262
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Schizophrenia; Oxytocin; Social Cognition; Psychotic Disorders

Keywords

Oxytocin; Syntocinon; Social Cognition; Schizophrenia; Psychosis; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorders

Outcome Measures

Primary Outcomes (1)

• Change in Social Cognition Task Performance

  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.

  Through study completion, 2-3 weeks

Secondary Outcomes (2)

• Physiological Measurements

  Through study completion, 2-3 weeks

• Questionnaire

  At baseline visit, up to 4 hours

Study Arms (2)

Oxytocin

EXPERIMENTAL

40 IU Oxytocin

Drug: Oxytocin

Saline Nasal Spray

PLACEBO COMPARATOR

Placebo Comparator

Drug: Saline Nasal Spray

Interventions

Oxytocin DRUG

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

Also known as: Syntocinon

Oxytocin

Saline Nasal Spray DRUG

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

Also known as: Placebo

Saline Nasal Spray

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco Veterans Affairs Medical Center: collaborator

Study Sites (2)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

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

Study Officials

• Josh D Woolley, MD/PhD

  University of California San Francisco, San Francisco Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 2, 2015
• Study Start: October 1, 2010
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

US (2)