Daily Intranasal Oxytocin for Childhood-Onset Schizophrenia
| Status: | Terminated |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 10 - 99 |
| Updated: | 7/8/2017 |
| Start Date: | October 5, 2012 |
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.
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.
- 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.
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.
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.
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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