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Adult Study Oxytocin - Behavioral (ASO-Behavioral)

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ClinicalTrials.gov Identifier: NCT02567032
Recruitment Status : Recruiting
First Posted : October 2, 2015
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
San Francisco Veterans Affairs Medical Center
Information provided by (Responsible Party):
Joshua Woolley, University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Oxytocin Social Cognition Psychotic Disorders Drug: Oxytocin Drug: Saline Nasal Spray Early Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - Behavioral
Study Start Date : October 2010
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
40 IU Oxytocin
Drug: Oxytocin
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Other Name: Syntocinon

Placebo Comparator: Saline Nasal Spray
Placebo Comparator
Drug: Saline Nasal Spray
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Other Name: Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567032


Contacts
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Contact: Lisa Lin, BA 415-221-4810 ext 23318 LISA.LIN@UCSF.EDU
Contact: Jessica Buffington, BA 415-221-4810 ext 25164 Jessica.Buffington@ucsf.edu

Locations
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United States, California
San Francisco Veterans Affairs Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Josh Woolley, MD/PhD    415-221-4810 ext 4117    josh.woolley@ucsf.edu   
Principal Investigator: Josh Woolley, MD/PhD         
University of California, San Francisco Active, not recruiting
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
San Francisco Veterans Affairs Medical Center
Investigators
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Principal Investigator: Josh D Woolley, MD/PhD University of California San Francisco, San Francisco Veterans Affairs Medical Center

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Responsible Party: Joshua Woolley, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02567032     History of Changes
Other Study ID Numbers: 10-02262
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joshua Woolley, University of California, San Francisco:
Oxytocin
Syntocinon
Social Cognition
Schizophrenia
Psychosis
Schizoaffective Disorder
Schizophreniform Disorder
Psychotic Disorders

Additional relevant MeSH terms:
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Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs