Adult Study Oxytocin - Behavioral
| Status: | Recruiting |
|---|---|
| Conditions: | Cognitive Studies, Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 6/6/2018 |
| Start Date: | October 2010 |
| End Date: | December 2020 |
| Contact: | Lisa Lin, BA |
| Email: | LISA.LIN@UCSF.EDU |
| Phone: | 415-221-4810 |
Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - 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.
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.
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.
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.
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
We found this trial at
2
sites
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San Francisco, California 94121
Principal Investigator: Josh Woolley, MD/PhD
Phone: 415-221-4810
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