Adult Study Oxytocin - fMRI (ASO-fMRI)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia.
Aim 1: To examine the effects of exogenous oxytocin on patterns of neural activation as measured by fMRI during a well-characterized affect-labeling task in patients with recent-onset schizophrenia and healthy comparison subjects.
Hypothesis A: Patients will exhibit amygdalar hyperactivity and PNS hypo-activity when passively viewing faces, which will be normalized by administration of oxytocin.
Hypothesis B: Patients will exhibit hypo-activity of the vPFC when affectively labeling faces and this hypo-activity will be normalized by oxytocin administration.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria for Patients:
- Male
- SCID-IV confirmed diagnosis of schizophrenia or schizoaffective disorder
- Clinically stable
- No changes to medications for the past week
Inclusion Criteria for Healthy Controls:
- Male
- SCID-IV confirmed no diagnosis of a current Axis I disorder within the last year
Exclusion Criteria for Patients and Healthy Controls:
- Meeting criteria for current substance abuse or dependence or illicit drug use within the last month (nicotine use is acceptable) as determined by a Urine Toxicology Drug Screening
- Any illness that affects the nasal passages and impairs the delivery of a nasal spray
- Presence of any neurological or significant medical disorder, including medical illnesses that could interfere with physiological recording such as cardiac arrhythmias
- A pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos
- Pregnancy
- Claustrophpbia
- Hearing difficulties
- A history of seizures
- Failure to receive a passing score on the reading test
Additional Exclusion Criteria for Patients and Healthy Controls:
- Taking any psychotropic medication or any medication that affects the autonomic or cardiovascular systems.
- Schizophrenia or other psychotic disorder in a first degree relative
- Failure to receive a passing score on the MOCA
Trial design
Primary purpose
Allocation
Interventional model
Masking
59 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal