Phase 2 N=39 Randomized Double-blind Treatment

Oxytocin as Adjunctive Treatment of Schizophrenia

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT01568528 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: Eye Tracking: Fixation Count — 6.78; 9.19; 9.88; 7.94 Number of face fixations

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Oxytocin (Drug); Placebo (Drug); Control (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Emory University
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Eye Tracking: Fixation Count	6.78; 9.19; 9.88; 7.94; 8.34; 7.38	—
PRIMARY Eye Tracking: Dwell Duration Time	1.11; 1.01; 1.18; 1.26; 1.04; 0.99	—
PRIMARY Social Reward Ball-tossing Task	8.91; 15.38; 25.64	—
PRIMARY Non-Social Reward Ball-tossing Game	10.53; 6.29; 28.20	—
PRIMARY Facial Emotion Identification Task	12.16; 11; 9.44	—

Summary

The focus of the current project is to advance our understanding of the effects of oxytocin (OT) on components of social cognition in schizophrenia (SCZ). Despite the rapid increase in our understanding of the role of OT in rodent models of social behavior and an explosion of interest in the prosocial effects of OT in healthy controls, little work has been done to dissect the potential effects of OT on SCZ subjects with social deficits. Social deficits are a crucial aspect of the functional impairments that limit the rehabilitation of patients with SCZ. In particular, SCZ patients with enduring negative symptoms (deficit syndrome, Kirkpatrick et al. 1989) have prominent social deficits as a core feature of this subtype of the illness. Our currently available medications do very little to improve these social deficits. Hence it is of utmost public health importance to address the knowledge gap regarding the potential of OT to improve social function in this illness. Intact social function depends on the competent functioning of several cognitive domains that subserve perception of social cues and the generation of motivated social behavior. We propose to conduct a pharmacological challenge study of OT vs. placebo administration to study the effects of OT on specific components of social cognition in male deficit syndrome SCZ subjects. Primary Hypothesis: Intranasal OT will improve social cognition in subjects with deficit syndrome SCZ.

Eligibility Criteria

Subjects for the study will be forty male VA patients with a diagnosis of schizophrenia. Diagnosis will be determined using the Structured Clinical Interview for DSM-IV Axis I Disorders/SCID-P (Spitzer et al. 1992). Subjects must be categorized as having a primary deficit syndrome on the Kirkpatrick Schedule for the Deficit Syndrome (Kirkpatrick et al. 1989).

Additional inclusion criteria:

Subjects must be between 18 and 65 years old at the time of study screening.
Subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
Subjects must have been psychiatrically and medically stable for 8 weeks prior to consent in the judgment of the Principal Investigator.
Subjects must have been maintained on a stable treatment of antipsychotics and/or other concomitant psychotropic treatment for at least 6 weeks prior to consent.
Subjects must have no more than a moderate severity rating on hallucinations and unusual thought content as shown by a score of ≤ 4 on the Positive and Negative Symptoms Scale (PANSS).
Subjects must be able to validly complete the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB), in the judgment of the consenting study staff person.
Subjects must have the visual, auditory, and motor capacity to use the computer software in the judgment of the consenting study staff person. Visual acuity must be at least 20/30 corrected.
Subjects must have a minimal level of extrapyramidal symptoms as shown by a Simpson-Angus Scale total score of no more than 6.
Subjects must have a minimal level of depressive symptoms as shown by a Calgary Depression Scale (CDSS) total score of no more than 10.

Exclusion criteria

Female sex
History of bipolar disorder
Active substance dependence within the prior 30 days (cigarette smoking is allowed)
Has had a psychiatric hospitalization in the 8 weeks prior to consent.
Suicidal or homicidal ideation in the previous six months
Subjects who have answered 'yes' to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the Columbia-Suicide Severity Rating Scale, C-SSRS, or who have answered 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the C-SSRS "Suicidal Behavior" portion shall be excluded from the study if ideation or behavior occurred within one month of consent. Subjects excluded for this reason will be referred for appropriate treatment.
History of mental retardation or pervasive developmental disorder
History of neurological disorder (e.g., traumatic brain injury, seizure disorder, Parkinson's Disease, dementia), loss of consciousness for more than 10 minutes due to head trauma, known HIV infection, or AIDS
Treatment with a benzodiazepine in the two weeks prior to consent.

Control Participants:

Inclusion Criteria

Male
Ages 18-65

Exclusion Criteria

Female
History of a psychotic disorder, or depression requiring medication
Active substance abuse or dependence within the prior 30 days
Medical admission within the past six months

Criteria to rule out subjects with medical problems likely to present a confound:

Known HIV infection or AIDS
History of TBI
Seizure disorder
Known Alzheimer's Disease or other dementia
Minimal cognitive impairment (MCI)
Parkinson's Disease
Unstable medical condition

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01568528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.