N/A
N=17
Oxytocin Treatment of Schizophrenia
Paranoia · Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01028677 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point — 7.25; 6.67; 4.38; 6.17 number of correct responses — p=.61
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- intranasal spray with oxytocin (Drug); nasal spray without oxytocin (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point |
7.25; 6.67; 4.38; 6.17; 7.13; 6.50 | .61 |
| PRIMARY Theory of Mind as Measured by the Eyes Test at 6 Weeks |
22.25; 22.17 | — |
| PRIMARY Theory of Mind as Measured by the Brune Test at 6 Weeks |
21.13; 22.00 | .03 sig |
| PRIMARY Social Perception as Measured by the Trustworthiness Task at 6 Weeks |
1.88; 11.33 | — |
| PRIMARY Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks |
88.00; 87.00; 21.60; 26.80; 23.80; 23.60 | .784 |
| SECONDARY Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks |
14.00; 18.50; 17.25; 17.17; 29.88; 32.67 | 0.008 sig |
Summary
Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves social cognition, social functioning and decreases paranoia and other psychotic symptoms in schizophrenia.
Participants: Up to 80 adults with schizophrenia for at least one year and with a high rating for paranoia.
Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal spray (6 insufflations/dose or 24 IU) for 6 weeks. Before, during and at the end of the trial, each subject will undergo social cognitive measures (primary outcomes) and psychiatric symptom ratings (secondary outcomes).
Eligibility Criteria
Inclusion Criteria
- Meeting DSM-IV criteria for paranoid or undifferentiated schizophrenia for at least 1 year.
- Scoring > or equal to 4 on the suspiciousness/persecution (paranoia) subscale of the Positive and Negative Symptoms Scale (PANSS), a full PANSS score > or equal to 60: stability of symptom severity and on the same medication(s) and dose(s) for at least 1 month; low to moderate depressive symptoms.
Exclusion Criteria
- Low literacy as indicated by an inability to read and understand the consent form.
- Dependence on substances other than tobacco or caffeine.
- Positive urine drug screen for illegal substances or drugs that have not been prescribed.
- Debilitating medical conditions (including AIDS; HIV infection alone will not be grounds for exclusion).
- Major surgery or trauma in the past year will be grounds for exclusion although subjects determined to be recovered and stable may be included at the discretion of the PI.
- Pregnancy, breast-feeding.
- Having given birth in the past 6 months or breast-feeding in the past 3 months.
- Individuals judged unable to learn self-administration of intranasal treatments and/or not sufficiently reliable to do so will be excluded.
- Abnormalities found during medical evaluation will be grounds for exclusion although subjects with laboratory measures barely outside the normal range may be included at the discretion of the Principal Investigator.
Data sourced from ClinicalTrials.gov (NCT01028677). 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.