Oxytocin Treatment of Schizophrenia (NCT01028677) | Clinical Trial Compass
CompletedNot Applicable
Oxytocin Treatment of Schizophrenia
United States17 participantsStarted 2009-11
Plain-language 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).
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point
Timeframe: 6 weeks
2
Theory of Mind as Measured by the Eyes Test at 6 Weeks
Timeframe: 6 weeks
3
Theory of Mind as Measured by the Brune Test at 6 Weeks
Timeframe: 6 weeks
4
Social Perception as Measured by the Trustworthiness Task at 6 Weeks
Timeframe: 6 weeks
5
Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks