Primary outcomeNumber· 6 Weeks
Clinical Global Impressions Scale - Improvement - Social
| Group | Value (participants) |
|---|---|
| Intranasal Oxytocin | 3 |
| Placebo | 1 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataIntranasal Oxytocin in the Treatment of Autism
NCTNCT00490802 (opens ClinicalTrials.gov in a new tab)Other id06-0230 0001 02 PS
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 19 participants (actual)
- Sponsor
- Evdokia Anagnostou · Indiv
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Jun 2006
- Primary completion
- Sept 2011
- Completion
- Apr 2012
- First posted
- 25 Jun 2007 (estimated)
- Last update posted
- 23 Oct 2015 (estimated)
- Conditions
- Autism
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2006200820102012
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to learn whether or not the drug called oxytocin is helpful in improving mood and social functioning in adults with autism.
Interventions
- OxytocinDrug
- PlaceboDrug
Arms2
Experimental
Intranasal Oxytocin
Subjects were given 24 IU intranasal oxytocin twice daily, in the morning and afternoon for 6 weeks.
Placebo comparator
Placebo
Subjects were given placebo twice daily, in the morning and afternoon for 6 weeks.
Primary outcomes3
Outcomes the sponsor listed as primary.
Clinical Global Impressions Scale - Improvement - Social
Time frame · 6 Weeks
Registry description
The Clinical Global Impressions Scale - Improvement - Social is a well validated measure employing a 7-point scale of clinical global impression of improvement ( 1- very much improved, 2 - much improved, 3 - minimally improved, 4 - no change, 5 - minimally worse, 6 - much worse, 7 - very much worse) that the clinician fills out after considering all the available information on the participant including the parent history, the examination in clinic, reports from the school and other sources. Therefore the score is filtered through the judgment of the clinician evaluator. The Week 6 Improvement Ratings were used to categorize patients as clinically improved (≤2) or not (\>2). Sixteen of the 19 patients (84%) had data at Week 6. For the remaining three subjects, Week 6 ratings were imputed using expectation-maximization methods and the earlier Clinical Global Impression ratings. In all three cases the imputed ratings were \>2 and the patients were classified as not improved.
Repetitive Behavior Scale - Revised
Time frame · 6 Weeks
Registry description
The Repetitive Behavior Scale - Revised was developed to capture the breadth of repetitive behaviors that are specific to autism and is a parent report measure. In particular, it consists of 43-items that tap six repetitive behavior subtypes: Stereotyped, Self-injurious, Compulsive, Ritualistic, Sameness, and Restricted Interests. Two scores were calculated (higher-order vs. lower-order repetitive behaviors) in an effort to decrease the number of variables analyzed. This is based on previous factor analysis that produced these two factors: higher order (ritualistic, sameness, compulsive and restricted subscales) and lower order (stereotypy and self-injury). 1. The higher order behaviors have 29 items that can be endorsed with a maximum score of 87 and a minimum score of 0 2. The lower order behaviors have 14 items that can be endorsed, with a maximum score of 42 and a minimum score of 0 In both cases, a lower score represents a positive response.
Diagnostic Analysis of Nonverbal Accuracy, Paralanguage Test
Time frame · 6 Weeks
Registry description
The Diagnostic Analysis of Nonverbal Accuracy is a measure of emotion recognition across multiple modalities. It consists of five subtests: the Adult Facial Expression Test, the Child Facial Expression Test, the Adult Paralanguage Test, the Child Paralanguage Test, and the Adult Posture Test. The Diagnostic Analysis of Nonverbal Accuracy has established reliability and validity for children as young as 3 and adults as old as 100. The subtests of the test vary on four basic core emotions: happiness, sadness, anger, and fear, and the test provides measures of both high intensity and low intensity emotional reactions. We utilized both the Child Paralanguage and Adult Paralanguage Tests, therefore the minimum score that can be obtained is 0 and the maximum is 48. A higher score represents a positive response.
Secondary outcomes(2)
Yale-Brown Obsessive-Compulsive Scale
Time frame · 6 Weeks
Registry description
The Yale-Brown Obsessive-Compulsive Scale is a clinician-rated questionnaire measuring the time spent, distress, interference, resistance, and control in relation to obsessions and compulsions based on a 5-point scale. This scale has excellent reliability and validity and is used as the gold standard to measure treatment challenges in all Obsessive-Compulsive Disorder clinical trials. The Yale-Brown Obsessive-Compulsive Scale Compulsion Subscale has been shown to be a reliable and valid scale in Autism Spectrum Disorder, and in measuring change in treatment studies of autism. The minimum score that can be obtained is 0 and the maximum score is 20. A lower score represents a positive response.
Social Responsiveness Scale
Time frame · 6 Weeks
Registry description
The Social Responsiveness Scale has been developed to measure autism related symptoms and focuses more on social function than social cognition. The Social Responsiveness Scale has been modified for adults by and we have obtained permission to use the adult scale, although it is not commercially available yet. The Social Responsiveness Scale measures social behaviors such as social awareness, information processing, and social motivation and yields a quantitative score that has been useful in endophenotype studies of Autism Spectrum Disorder. The minimum score that can be obtained is a 0 and the maximum raw score for subscales is 66, maximum total raw score is 153. A lower score represents a positive response.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· 6 Weeks
Repetitive Behavior Scale - Revised
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Intranasal Oxytocin | 17.7 | 16.2 |
| Placebo | 17.8 | 13.3 |
Primary outcomeMean· 6 Weeks
Diagnostic Analysis of Nonverbal Accuracy, Paralanguage Test
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Intranasal Oxytocin | 30.5 | 2.7 |
| Placebo | 35.2 | 4.7 |
Secondary and other outcome results(2)
Secondary outcomeMean· 6 Weeks
Yale-Brown Obsessive-Compulsive Scale
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Intranasal Oxytocin | 9.4 | 2.9 |
| Placebo | 8.1 | 2.5 |
Secondary outcomeMean· 6 Weeks
Social Responsiveness Scale
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Intranasal Oxytocin | 111.4 | 13.5 |
| Placebo | 96.5 | 13.0 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Intranasal OxytocinOxytocin : Intranasal Oxytocin | – | 0 / 10 | 9 / 10 |
| PlaceboDrug Placebo Comparator : Placebo Comparator | – | 0 / 9 | 5 / 9 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
More studies
1 study on this page
PubMed tag: none · 2012
Intranasal oxytocin versus placebo in the treatment of adults with autism spectrum disorders: a randomized controlled trial.
Anagnostou et al. 2012Molecular autismcited by 272
PMID 23216716PMC3539865DOI 10.1186/2040-2392-3-16PUB-23216716
CC BY
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedIffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2. PMID 37811711
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 60 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Male or female outpatients 18 to 60 years of age.
2. Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision. The diagnosis will be confirmed with Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule .
3. Have a Clinician's Global Impression-Severity score ≥ 4 (moderately ill) at Screening and Baseline.
4. If already receiving stable nonpharmacologic educational, behavioral, and/or dietary interventions, have continuous participation during the preceding 3 months prior to Screening and will not electively initiate new or modify ongoing interventions for the duration of the study.
5. Have normal physical examination and laboratory test results at Screening. If abnormal, the finding(s) must be deemed clinically insignificant by the Investigators.
6. The patient must be able to speak and understand English sufficiently to understand the nature of the study and to allow for the completion of all study assessments.
7. Have a normal Intelligence Quotient (\>70) supported by the Wechsler Abbreviated Scales of Intelligence.
Exclusion Criteria:
1. Patients born prior to 35 weeks gestational age.
2. Patients with any primary psychiatric diagnosis other than autism at Screening: a history of attention deficit hyperactivity disorder, bipolar disorder, psychosis, posttraumatic stress disorder, schizophrenia, or major depressive disorder.
3. Patients with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal magnetic resonance imaging/structural lesion of the brain.
4. Pregnant female patients.
5. Patients with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Patients with evidence or history of malignancy or any significant hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease.
6. Patients taking psychoactive medication(s) (e.g., stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clonidine).
7. Patients who plan to initiate or change nonpharmacologic interventions during the course of the study.
8. Patients unable to tolerate venipuncture procedures for blood sampling.
9. Patients who, in the Investigator's opinion, might not be suitable for the study.
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