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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000586-45 | EudraCT Number |
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| Name | Class |
|---|---|
| The Branco Weiss Fellowship | OTHER |
| Research Foundation Flanders | OTHER |
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The current trial aims to explore the neural and behavioral effects of oxytocin in autism spectrum disorders (ASD). Oxytocin is a nonapeptide produced by the paraventricular and supraoptic nuclei of the hypothalamus and is known to play a pivotal role in a variety of complex social behaviors. Initial studies showed that intranasal administration of oxytocin can have a positive effect on social functioning in ASD.
However, future studies are necessary to explore whether and how oxytocin effects neural processes in the brain underlying these behavioral improvements. This trial will not only measure behavioral enhancements, but will specifically focus on elucidating the associated neurophysiological changes by guiding the administration of oxytocin with regular neurophysiological assessments.
The present study is a monocentric, between-subjects, randomized, placebo-controlled trial. The investigators will recruit approximately 40 young-adult, male individuals with a clinical diagnosis of Autism Spectrum Disorder (ASD). Participants will be randomly allocated to an experimental group (Oxytocin (OT)) and a control group (Placebo (PL)). All participants will receive the same frequency and duration of intervention. Behavioral and neural outcome measures will be assessed at multiple time points in a period of a year. Participants will be tested at 5 occasions: before and after a single dose of nasal spray, after multiple doses of nasal spray (1 daily dose of nasal spray during 4 weeks), after a 4-week retention period and after a 1-year retention period. At each time point participants will be tested at both the behavioral and neural level. Test performance of both participant groups (OT vs PL) will be compared by measuring reaction times and accuracy rates in a computerized task assessing a person's ability to recognize bodily emotional states from point light displays. In addition, attachment, social functioning, restricted behaviour, general quality of life and mood will be assessed via self-reported questionnaires.
Functional MRI measurements will be performed in a 3T MR Philips Intera scanner. Before scanning, subjects will undergo a training session to familiarize them with the task instructions. In addition to the fMRI measurements, resting state fMRI and Diffusion Tensor Imaging (DTI) will also be performed to reveal alterations of the functional and structural connectivity between critical regions.
Statistical analysis of the behavioral data will have a between-subject factor of group (OT vs PL) and within-subject factors of time (change-from-baseline). Image analysis will be performed with Statistical Parametric Mapping (SPM) software. The investigators will contrast for either decreased or increased activation, as different regions may show divergent changes due to the received nasal spray (either OT or PL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Syntocinon (Oxytocin, product code RVG 03716) | Experimental | Administration via nasal spray |
|
| Placebo (Physiological water(sodium chloride (NaCl) solution)) | Placebo Comparator | Administration via nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Syntocinon (Oxytocin) | Drug | Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) After a Single Dose of Nasal Spray BOLD response (Blood-oxygen-level-dependent response) | Value at 30 minutes minus value at baseline |
| Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 4 weeks of nasal spray BOLD response (Blood-oxygen-level-dependent response) | Value at 4 weeks minus value at baseline |
| Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 8 weeks, including 4 weeks without nasal spray BOLD response (Blood-oxygen-level-dependent response) | Value at 8 weeks minus value at baseline |
| Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 52 weeks, including 48 weeks without nasal spray BOLD response (Blood-oxygen-level-dependent response) | Value at 52 weeks minus value at baseline |
| Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/Reaction Time) After a Single Dose of Nasal Spray | Change from baseline in performance on the emotion recognition task (accuracy/reaction time) after a single dose of nasal spray Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance. |
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Inclusion Criteria:
Exclusion Criteria:
MRI contraindications:
pacemaker, implanted defibrillator, ear implant / a cochlear implant, insulin or implanted pump, a neurostimulator or VP shunt, any metallic object in the eyes (metallic fragments)
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| Name | Affiliation | Role |
|---|---|---|
| Kaat Alaerts, PhD | KU Leuven | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37811711 | Derived | Iffland 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. |
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Participants were mainly recruited from the Expertise Centrum Autisme of the UZ Leuven between April 2015 and December 2016. Recruitment and patient contact were facilitated by our collaboration with Prof. Dr. Jean Steyaert, head of UZ Leuven ECA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Syntocinon (Oxytocin, Product Code RVG 03716) | Administration via nasal spray Syntocinon (Oxytocin): Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray |
| FG001 | Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Administration via nasal spray Placebo (Physiological water (solution of sodium chloride (NaCl) in water)): Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| From Study Start to 1-month Follow-up |
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| ||||||||||||||||||
| 1-year Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Syntocinon (Oxytocin, Product Code RVG 03716) | Administration via nasal spray Syntocinon (Oxytocin): Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Assessed via self-report. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) After a Single Dose of Nasal Spray BOLD response (Blood-oxygen-level-dependent response) | 1 subject lost in Syntocinon group due to subject withdrawal. 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion) | Posted | Mean | Standard Deviation | Change-from-baseline (BOLD response) | Value at 30 minutes minus value at baseline |
|
Adverse event data were collected over a period of (approximately) four weeks.
Adverse event data were collected via weekly journal entries. In the journal we provided an extensive list of potential adverse events and a blank space below the list to write down adverse events not mentioned in the list. Participants were asked to indicate whether or not they had experienced the event, when it started, how long it lasted, and the severity of the adverse event (mild, moderate, severe).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Syntocinon (Oxytocin, Product Code RVG 03716) | Administration via nasal spray Syntocinon (Oxytocin): Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal irritation/ runny nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Nasal irritation/ runny nose due to the nasal spray use |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Kaat Alaerts | KU Leuven | 16 37 64 46 | +32 | kaat.alaerts@kuleuven.be |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo (Physiological water (solution of sodium chloride (NaCl) in water)) | Other | Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray |
|
| Value at 30 minutes minus value at baseline |
| Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray | Change from baseline in brain connectivity during rest (resting-state fMRI) after 4 weeks of nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity) | Value at 4 weeks minus value at baseline |
| Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray | Change from baseline in brain connectivity during rest (resting-state fMRI) after 8 weeks, including 4 weeks without nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity) | Value at 8 weeks minus value at baseline |
| Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray | Change from baseline in brain connectivity during rest (resting-state fMRI) after 52 weeks, including 48 weeks without nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity) | Value at 52 weeks minus value at baseline |
| Value at 30 minutes minus value at baseline |
| Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 4 Weeks of Nasal Spray | Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 4 weeks of nasal spray. Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance. | Value at 4 weeks minus value at baseline |
| Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 8 Weeks (Including 4 Weeks Without Nasal Spray) | Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 8 weeks (including 4 weeks without nasal spray). Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance. | Value at 8 weeks minus value at baseline |
| Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 52 Weeks (Including 48 Weeks Without Nasal Spray) | Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 52 weeks (including 48 weeks without nasal spray) Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance. | Value at 52 weeks minus value at baseline |
| Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 4 Weeks of Nasal Spray | The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale. | Value at 4 weeks minus value at baseline |
| Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 8 Weeks, Including 4 Weeks Without Nasal Spray | The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale. | Value at 8 weeks minus value at baseline |
| Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 52 Weeks, Including 48 Weeks Without Nasal Spray | The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QOL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale. | Value at 52 weeks minus value at baseline |
| Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray | Change from baseline in scores on one questionnaire assessing mood (Profile of Mood States - POMS) after a single dose of nasal spray. This instrument comprises emotional adjectives subdivided in five domains: tension (6 items). depression (8 items). vigor (5 items). fatigue (6 items) and anger (7 items) which have to be rated on a five-point Likert scale ranging from 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a lot), to 4 (extremely). Only for the vigor scale, higher scores indicate improvement. | Value at 30 minutes minus value at baseline |
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| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) |
Administration via nasal spray Placebo (Physiological water (solution of sodium chloride (NaCl) in water)): Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Only men were included in the study. | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Total IQ | 6-subtest short version of the Wechsler Adult Intelligence Scale-IV Dutch version: Block design, Digit span, Similarities, Vocabulary, Symbol search and Visual puzzles | Mean | Standard Deviation | units on a scale |
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| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) |
Administration via nasal spray Placebo (Physiological water (solution of sodium chloride (NaCl) in water)): Placebo nasal spray. |
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| Primary | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 4 weeks of nasal spray BOLD response (Blood-oxygen-level-dependent response) | 1 subject lost in Syntocinon group due to subject withdrawal. 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion) | Posted | Mean | Standard Deviation | Change-from-baseline (BOLD response) | Value at 4 weeks minus value at baseline |
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| Primary | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 8 weeks, including 4 weeks without nasal spray BOLD response (Blood-oxygen-level-dependent response) | 1 subject lost in Syntocinon group due to subject withdrawal. 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion) | Posted | Mean | Standard Deviation | Change-from-baseline (BOLD response) | Value at 8 weeks minus value at baseline |
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| Primary | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 52 weeks, including 48 weeks without nasal spray BOLD response (Blood-oxygen-level-dependent response) | 1 subject lost in Syntocinon group due to subject withdrawal. (+ 3 additional participants lost for 1-year follow-up) 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion) (+ 3 additional participants lost for 1-year follow-up) | Posted | Mean | Standard Deviation | Change-from-baseline (BOLD response) | Value at 52 weeks minus value at baseline |
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| Primary | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity) | 1 subject lost in Syntocinon group due to subject withdrawal. 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion) | Posted | Mean | Standard Deviation | Change-from-base z-transformed r-value | Value at 30 minutes minus value at baseline |
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| Primary | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray | Change from baseline in brain connectivity during rest (resting-state fMRI) after 4 weeks of nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity) | 1 subject lost in Syntocinon group due to subject withdrawal. 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion) | Posted | Mean | Standard Deviation | Change-from-base z-transformed r-value | Value at 4 weeks minus value at baseline |
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| Primary | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray | Change from baseline in brain connectivity during rest (resting-state fMRI) after 8 weeks, including 4 weeks without nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity) | Posted | Mean | Standard Deviation | Change-from-base z-transformed r-value | Value at 8 weeks minus value at baseline |
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| Primary | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray | Change from baseline in brain connectivity during rest (resting-state fMRI) after 52 weeks, including 48 weeks without nasal spray Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity) | 1 subject lost in Syntocinon group due to subject withdrawal. (+ 3 additional participants lost for 1-year follow-up) 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion) (+ 3 additional participants lost for 1-year follow-up) | Posted | Mean | Standard Deviation | Change-from-base z-transformed r-value | Value at 52 weeks minus value at baseline |
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| Secondary | Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/Reaction Time) After a Single Dose of Nasal Spray | Change from baseline in performance on the emotion recognition task (accuracy/reaction time) after a single dose of nasal spray Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance. | 1 subject lost in Syntocinon group due to subject withdrawal. 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion) | Posted | Mean | Standard Deviation | Change in performance (acc/rt ratio) | Value at 30 minutes minus value at baseline |
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| Secondary | Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 4 Weeks of Nasal Spray | Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 4 weeks of nasal spray. Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance. | 1 subject lost in Syntocinon group due to subject withdrawal. 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion) | Posted | Mean | Standard Deviation | Change in performance (acc/rt ratio) | Value at 4 weeks minus value at baseline |
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| Secondary | Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 8 Weeks (Including 4 Weeks Without Nasal Spray) | Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 8 weeks (including 4 weeks without nasal spray). Emotion recognition from point-light displays conveying biological motion. Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance. | 1 subject lost in Syntocinon group due to subject withdrawal. 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion) | Posted | Mean | Standard Deviation | Change in performance (acc/rt ratio) | Value at 8 weeks minus value at baseline |
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| Secondary | Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 52 Weeks (Including 48 Weeks Without Nasal Spray) | Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 52 weeks (including 48 weeks without nasal spray) Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance. | 1 subject lost in Syntocinon group due to subject withdrawal. (+ 3 additional participants lost for 1-year follow-up) 1 subject lost in Placebo group due to low data quality (excessive in-scanner head motion) (+ 3 additional participants lost for 1-year follow-up) | Posted | Mean | Standard Deviation | Change in performance (acc/rt ratio) | Value at 52 weeks minus value at baseline |
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| Secondary | Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 4 Weeks of Nasal Spray | The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale. | Intention-to-treat Syntocinon: IPPA Mother, IPPA Father (n= 21) (listwise missing data: n= 1) SRS-A informant (n= 17) (missing baseline data: n= 5) Placebo: RBS-R, WHO-QOL (n= 17) (missing baseline data n= 1) SRS-A informant (n= 15) (missing baseline data: n= 3) | Posted | Mean | Standard Deviation | Change from base (units on a scale) | Value at 4 weeks minus value at baseline |
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| Secondary | Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 8 Weeks, Including 4 Weeks Without Nasal Spray | The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale. | Intention-to-treat Syntocinon: IPPA Mother, IPPA Father (n= 21) (listwise missing data: n= 1) SRS-A informant (n= 17) (missing baseline data: n= 5) Placebo: RBS-R, WHO-QOL (n= 17) (missing baseline data n= 1) SRS-A informant (n= 15) (missing baseline data: n= 3) | Posted | Mean | Standard Deviation | Change from base (units on a scale) | Value at 8 weeks minus value at baseline |
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| Secondary | Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 52 Weeks, Including 48 Weeks Without Nasal Spray | The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness. The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors. The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale. Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents. World Health Organization Quality of Life - Bref (WHO-QOL) uses a five-point Likert scale. Higher scores indicate better quality of life. Profile of Mood States (POMS). five-point Likert scale. | Intention-to-treat Syntocinon: IPPA Mother, IPPA Father (n= 21) (listwise missing data: n= 1) SRS-A informant (n= 17) (missing baseline data: n= 5) Placebo: RBS-R, WHO-QOL (n= 17) (missing baseline data n= 1) SRS-A informant (n= 15) (missing baseline data: n= 3) | Posted | Mean | Standard Deviation | Change from base (units on a scale) | Value at 52 weeks minus value at baseline |
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| Secondary | Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray | Change from baseline in scores on one questionnaire assessing mood (Profile of Mood States - POMS) after a single dose of nasal spray. This instrument comprises emotional adjectives subdivided in five domains: tension (6 items). depression (8 items). vigor (5 items). fatigue (6 items) and anger (7 items) which have to be rated on a five-point Likert scale ranging from 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a lot), to 4 (extremely). Only for the vigor scale, higher scores indicate improvement. | Posted | Mean | Standard Deviation | Change from base (units on a scale) | Value at 30 minutes minus value at baseline |
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| 0 |
| 22 |
| 0 |
| 22 |
| 2 |
| 22 |
| EG001 | Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Administration via nasal spray Placebo (Physiological water (solution of sodium chloride (NaCl) in water)): Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray | 0 | 18 | 0 | 18 | 3 | 18 |
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Not provided
Not provided
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| SRS-A informant-based |
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| RBS-R |
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| SAAM avoidance |
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| SAAM security |
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| SAAM anxiety |
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| IPPA Peers |
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| IPPA Mother |
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| IPPA Father |
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| WHO-QOL |
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| POMS - Tension |
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| POMS - Anger |
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| POMS - Depression |
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| POMS - Vigor |
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| POMS - Fatigue |
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| SRS-A informant-based |
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| RBS-R |
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| SAAM avoidance |
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| SAAM security |
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| SAAM anxiety |
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| IPPA Peers |
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| IPPA Mother |
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| IPPA Father |
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| WHO-QOL |
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| POMS - Tension |
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| POMS - Anger |
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| POMS - Depression |
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| POMS - Vigor |
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| POMS - Fatigue |
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| SRS-A informant-based |
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| RBS-R |
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| SAAM avoidance |
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| SAAM security |
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| SAAM anxiety |
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| IPPA Peers |
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| IPPA Mother |
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| IPPA Father |
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| WHO-QOL |
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| POMS - Tension |
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| POMS - Anger |
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| POMS - Depression |
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| POMS - Vigor |
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| POMS - Fatigue |
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| POMS - Depression |
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| POMS - Vigor |
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| POMS - Fatigue |
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