Adult Study Oxytocin - Behavioral (ASO-Behavioral)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02567032|
Recruitment Status : Recruiting
First Posted : October 2, 2015
Last Update Posted : June 4, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
40 IU 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
Drug: Saline Nasal Spray
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Other Name: Placebo
- 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.
- 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.
- 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.
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
|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|
|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 email@example.com|
|Principal Investigator: Josh Woolley, MD/PhD|
|University of California, San Francisco||Active, not recruiting|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Josh D Woolley, MD/PhD||University of California San Francisco, San Francisco Veterans Affairs Medical Center|