Childhood Onset Psychotic DisordersPhase 1/2NCT01712646
Daily Intranasal Oxytocin for Childhood-Onset Schizophrenia
A Phase 1/2 study testing Intranasal Oxytocin in people with Childhood Onset Psychotic Disorders and Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 99 years
- Conditions the study is for
- Childhood Onset Psychotic Disorders, Schizophrenia
- What is being tested?
- Intranasal Oxytocin
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2012to 20 Jun 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Use of Daily, Intranasal Oxytocin for the Treatment of Childhood-Onset Schizophrenia (COS), a Randomized Double-Blind Trial
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.
Read more
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.
Read the detailed description
Background:
Recent studies with intranasal oxytocin administration indicate moderate efficacy in symptom reduction in adult patients with schizophrenia, and moderate to good response in improving social cognition in patients with autism. The majority (about 75%) of patients with childhood-onset schizophrenia (COS) continue to show impairing social and psychotic symptoms after drug treatment optimization, and almost 30% of children with COS have co-morbid autism spectrum disorder (ASD). Oxytocin may be a safe and effective adjunctive treatment to improve social cognition, reduce anxiety, and indirectly reduce psychotic symptoms in medication-stable COS patients.
Objective:
To study whether intranasal oxytocin (study medication) would be safe, improve emotional/social cognition, and reduce symptom severity in clinically stable COS children and whether the study medication would also result in specific neurocircuitry changes, as measured by multimodal neuroimaging.
Study Population:
72 patients (36 per group) with COS, ages 10 and above will be recruited. All patients will be on stable medications for at least one month prior to this study.
Design:
Two-week double-blind, placebo-controlled, parallel design trial of daily intranasal oxytocin. Subsequent to the study period, a two-week extension of open label study medication will be offered to all participants, regardless of study group assignment.
Outcome Measures:
Primary Outcome Measures:
To evaluate the safety of intranasal oxytocin in COS patients.
To assess whether intranasal administration of oxytocin will improve both positive and negative symptoms of schizophrenia compared to placebo, as measured by PANSS, SAPS, SANS, and BPRS.
To evaluate whether intranasal oxytocin has significant effects on the social and emotional processing and behavior of children with COS, as measured by the Diagnostic Analysis of Nonverbal Behavior (DANVA-2), Developmental Neuropsychological Assessment (NEPSY-2) standardized social perception battery, Brune Theory of Mind Pictures Stories Task, Reading the Mind in the Eyes Test. Social Responsiveness Scale (SRS).
To measure alterations in neurocircuitry after oxytocin administration, as measured by fMRI, DTI, and MEG.
To evaluate changes in blood plasma oxytocin levels measured over the course of the study.
- Conditions
- Childhood Onset Psychotic Disorders, Schizophrenia
- Being tested
- Intranasal Oxytocin
- Keywords
- Oxytocin, Childhood Onset Schizophrenia, Double Blind
- Medical subject headings
- Schizophrenia, Schizophrenia, Childhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal OxytocinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study start5 Oct 2012
- Primary completion20 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Childhood Onset Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Judith L Rapoport, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712646
- Sponsor's protocol ID
- 130004
- Other IDs
- 13-M-0004
- Status last verified
- 20 Jun 2016
- First submitted
- 20 Oct 2012
- Last updated
- 7 Jul 2017
- Results posted
- No
Publications
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.
PubMed 3215919Watkins 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.
PubMed 3235494Russell 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.
PubMed 2738007Berman 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.
PubMed 26493637
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Daily, Intranasal Oxytocin for the Treatment of Childhood-Onset Schizophrenia (COS), a Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT01712646
- Acronym / sponsor ID
- 130004
- Conditions
- Childhood Onset Psychotic Disorders, Schizophrenia
- Keywords
- Oxytocin, Childhood Onset Schizophrenia, Double Blind
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 5 Oct 2012
- Primary completion
- 20 Jun 2016 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Recent studies with intranasal oxytocin administration indicate moderate efficacy in symptom reduction in adult patients with schizophrenia, and moderate to good response in improving social cognition in patients with autism. The majority (about 75%) of patients with childhood-onset schizophrenia (COS) continue to show impairing social and psychotic symptoms after drug treatment optimization, and almost 30% of children with COS have co-morbid autism spectrum disorder (ASD). Oxytocin may be a safe and effective adjunctive treatment to improve social cognition, reduce anxiety, and indirectly reduce psychotic symptoms in medication-stable COS patients.
Objective:
To study whether intranasal oxytocin (study medication) would be safe, improve emotional/social cognition, and reduce symptom severity in clinically stable COS children and whether the study medication would also result in specific neurocircuitry changes, as measured by multimodal neuroimaging.
Study Population:
72 patients (36 per group) with COS, ages 10 and above will be recruited. All patients will be on stable medications for at least one month prior to this study.
Design:
Two-week double-blind, placebo-controlled, parallel design trial of daily intranasal oxytocin. Subsequent to the study period, a two-week extension of open label study medication will be offered to all participants, regardless of study group assignment.
Outcome Measures:
Primary Outcome Measures:
To evaluate the safety of intranasal oxytocin in COS patients.
To assess whether intranasal administration of oxytocin will improve both positive and negative symptoms of schizophrenia compared to placebo, as measured by PANSS, SAPS, SANS, and BPRS.
To evaluate whether intranasal oxytocin has significant effects on the social and emotional processing and behavior of children with COS, as measured by the Diagnostic Analysis of Nonverbal Behavior (DANVA-2), Developmental Neuropsychological Assessment (NEPSY-2) standardized social perception battery, Brune Theory of Mind Pictures Stories Task, Reading the Mind in the Eyes Test. Social Responsiveness Scale (SRS).
To measure alterations in neurocircuitry after oxytocin administration, as measured by fMRI, DTI, and MEG.
To evaluate changes in blood plasma oxytocin levels measured over the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 10 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal Oxytocin | Drug | – |
Primary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Background: PubMed 3215919Asarnow 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.
- Background: PubMed 3235494Watkins 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.
- Background: PubMed 2738007Russell 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.
- Derived from this study: PubMed 26493637Berman 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith L Rapoport, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intranasal Oxytocin in people with Childhood Onset Psychotic Disorders and Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood plasma oxytoxin levels. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01712646, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.