Daily Intranasal Oxytocin for Childhood-Onset Schizophrenia

NCT01712646 | Terminated Phase 1

• 2 other identifiers: 13000413-M-0004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Onset Psychotic Disorders; Schizophrenia

Keywords

Oxytocin; Childhood Onset Schizophrenia; Double Blind

Outcome Measures

Primary Outcomes (5)

• Blood plasma oxytoxin levels

• Neuocircuitry alterations in amygdale/cingulated

• Brain activity alterations during exposure to social stimuli

• Improved psychosis/anxiety symptoms

• Improved DANVA-2/NEPSY-2/social interaction scores

Interventions

Intranasal Oxytocin DRUG

Eligibility Criteria

• Age: 10 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• COS patients (age 10 and above) recruited, enrolled, and diagnosed under the screening protocol 03-M-0035.
• Have been stable on their medications for at least one month prior to enrollment in this study, with the exception of occasional use of prn (as needed) medication. There are no contraindications to oxytocin; therefore, all medications are permitted.
• Continued problems in social/emotional domains, as evidenced by problems with interpersonal relationships (e.g., poor ability to relate with others, make friends, have meaningful social interactions), emotional processing (e.g., difficulty interpreting emotions, inappropriate emotional responses, significant anxiety around activities of daily living, lack of empathy), and/or residual symptoms of schizophrenia (e.g., hallucinations, delusions, flat affect, disorganized thinking/behavior), despite medication.

You may not qualify if:

• Any major neurological illness (e.g., epilepsy, brain tumors, metabolic disorders).
• Is pregnant, plans on becoming pregnant during the study, or is actively breast-feeding.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Asarnow JR, Ben-Meir S. Children with schizophrenia spectrum and depressive disorders: a comparative study of premorbid adjustment, onset pattern and severity of impairment. J Child Psychol Psychiatry. 1988 Jul;29(4):477-88. doi: 10.1111/j.1469-7610.1988.tb00738.x.

  PMID: 3215919 BACKGROUND

• Watkins JM, Asarnow RF, Tanguay PE. Symptom development in childhood onset schizophrenia. J Child Psychol Psychiatry. 1988 Nov;29(6):865-78. doi: 10.1111/j.1469-7610.1988.tb00759.x.

  PMID: 3235494 BACKGROUND

• Russell AT, Bott L, Sammons C. The phenomenology of schizophrenia occurring in childhood. J Am Acad Child Adolesc Psychiatry. 1989 May;28(3):399-407. doi: 10.1097/00004583-198905000-00017.

  PMID: 2738007 BACKGROUND

• Berman RA, Gotts SJ, McAdams HM, Greenstein D, Lalonde F, Clasen L, Watsky RE, Shora L, Ordonez AE, Raznahan A, Martin A, Gogtay N, Rapoport J. Disrupted sensorimotor and social-cognitive networks underlie symptoms in childhood-onset schizophrenia. Brain. 2016 Jan;139(Pt 1):276-91. doi: 10.1093/brain/awv306. Epub 2015 Oct 22.

  PMID: 26493637 DERIVED

MeSH Terms

Conditions

Schizophrenia; Schizophrenia, Childhood

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurodevelopmental Disorders

Study Officials

• Judith L Rapoport, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2012
• First Posted: October 23, 2012
• Study Start: October 5, 2012
• Primary Completion: June 20, 2016
• Last Updated: July 7, 2017

Record last verified: 2016-06-20

Locations

US (1)