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NCT01712646 · ClinicalTrials.gov registry record · Phase 1
Daily Intranasal Oxytocin for Childhood-Onset Schizophrenia
A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01712646 is a Phase 1 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 18 participants.
The verdict
NCT01712646, a Phase 1 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Background: \- Oxytocin is a chemical that the brain normally produces. It plays an important part in the way humans and other animals act in social and emotional situations. Adults with schizophrenia have been studied to see if oxytocin can reduce some symptoms of schizophrenia, such as hearing voices, feeling suspicious, and not feeling interested in daily life. These studies show that oxytocin may help. However, it has not been studied in children who develop schizophrenia. Researchers want to see if oxytocin, given as a nasal spray, is safe and can reduce schizophrenia symptoms in children. Objectives: \- To see if an oxytocin nasal spray can reduce schizophrenia symptoms in children. Eligibility: \- Children above 10 years of age who have childhood-onset schizophrenia, and have schizophrenia symptoms in spite of taking medication. Design: * This study will last 4 weeks. Participants will stay in the hospital for the entire period of the study. Participants may also have an extra 2 weeks of study medication and 1 week of testing immediately following the initial 4 weeks. * Participants will be screened with a physical exam and medical and psychiatric history. They will provide blood and urine samples, and have imaging studies of the brain. They will also have tests to look at their social and emotional functioning. These tests will take 1 week to perform. * Participants will have either oxytocin or placebo nasal spray twice daily for 2 weeks. * At the end of the 2-week period with nasal spray, there will be 1 week with no nasal spray. All the tests of week 1 will be repeated. * The optional extra 3 weeks (2 weeks with oxytocin and one week for testing) will be similar to the second, third, and fourth weeks of the study. All participants will have oxytocin during this period.
Interventions
- DRUG Intranasal Oxytocin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-10-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01712646
The ClinicalTrials.gov registry entry for NCT01712646 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intranasal Oxytocin is the first listed.
NCT01712646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01712646 about?
NCT01712646 is a clinical study titled "Daily Intranasal Oxytocin for Childhood-Onset Schizophrenia". Background: \- Oxytocin is a chemical that the brain normally produces. It plays an important part in the way humans and other animals act in social and emotional situations. Adults with schizophrenia have been studied to see if oxytocin can reduce some symptoms of schizophrenia, such as hearing vo...
What is the current status of trial NCT01712646?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2012-10-05.
What interventions are being tested in trial NCT01712646?
The interventions under investigation include: Intranasal Oxytocin (DRUG).
Who is sponsoring clinical trial NCT01712646?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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