Autism Spectrum Disorders
Conditions
Keywords
Oxytocin, Autism Spectrum Disorders
Brief summary
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.
Detailed description
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).
Interventions
DRUGSyntocinon (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
OTHERPlacebo (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
Sponsors
The Branco Weiss Fellowship
Research Foundation Flanders
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Autism Spectrum Disorder, Asperger Syndrome or Autism * Male * Age between 18 and 40 years old
Exclusion criteria
* Associated neuro(psycho)logical disorder (i.e. epilepsy, concussion, stroke) * Eye sight worse than + or - 7 * Genetic syndrome * Color blindness * Any contraindication to neuroimaging research as assessed with the MRI screening list: 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray | Value at 52 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 Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity) |
| Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray | Value at 30 minutes minus value at baseline | 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) |
| Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray | Value at 4 weeks minus value at baseline | 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) |
| Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray | Value at 8 weeks minus value at baseline | 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) |
| Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray | Value at 52 weeks minus value at baseline | 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) |
| Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray | Value at 30 minutes minus value at baseline | 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) |
| Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray | Value at 4 weeks minus value at baseline | 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) |
| Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray | Value at 8 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 Amygdala connectivity (Change-from-baseline z-transformed r-value) Higher z-transformed r-value indicates higher connectivity (higher correlated brain activity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/Reaction Time) After a Single Dose of Nasal Spray | Value at 30 minutes minus value at baseline | 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. |
| Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 4 Weeks of Nasal Spray | Value at 4 weeks minus value at baseline | 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. |
| Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 8 Weeks (Including 4 Weeks Without Nasal Spray) | Value at 8 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). 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. |
| Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 52 Weeks (Including 48 Weeks Without Nasal Spray) | Value at 52 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) Accuracy (acc) is measured in % of correct responses. Reaction time (rt) is measured in milliseconds. Higher (accuracy/ reaction time) ratio indicates better performance. |
| 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 | Value at 4 weeks minus value at baseline | 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. |
| 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 | Value at 8 weeks minus value at baseline | 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. |
| 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 | Value at 52 weeks minus value at baseline | 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. |
| Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray | Value at 30 minutes minus value at baseline | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 22 |
| 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 | 18 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1-year Follow-up | Lost to Follow-up | 3 | 4 |
| From Study Start to 1-month Follow-up | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Syntocinon (Oxytocin, Product Code RVG 03716) | Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Total |
|---|---|---|---|
| Age, Continuous | 25.00 years STANDARD_DEVIATION 4.86 | 24.00 years STANDARD_DEVIATION 5.55 | 24.38 years STANDARD_DEVIATION 5.11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 18 Participants | 40 Participants |
| Region of Enrollment Belgium | 22 participants | 18 participants | 38 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 22 Participants | 18 Participants | 40 Participants |
| Total IQ | 102.27 units on a scale STANDARD_DEVIATION 12.45 | 104.61 units on a scale STANDARD_DEVIATION 21.59 | 104.24 units on a scale STANDARD_DEVIATION 15.72 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 18 |
| other Total, other adverse events | 2 / 22 | 3 / 18 |
| serious Total, serious adverse events | 0 / 22 | 0 / 18 |
Outcome results
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)
Time frame: Value at 4 weeks minus value at baseline
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray | Brain activity - Superior temporal sulcus | -0.10 Change-from-baseline (BOLD response) | Standard Deviation 0.59 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray | Brain activity - Amygdala | -0.09 Change-from-baseline (BOLD response) | Standard Deviation 0.46 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray | Brain activity - Superior temporal sulcus | -0.29 Change-from-baseline (BOLD response) | Standard Deviation 0.68 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray | Brain activity - Amygdala | 0.06 Change-from-baseline (BOLD response) | Standard Deviation 0.45 |
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)
Time frame: Value at 52 weeks minus value at baseline
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray | Brain activity - Superior temporal sulcus | -0.18 Change-from-baseline (BOLD response) | Standard Deviation 0.56 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray | Brain activity - Amygdala | -0.21 Change-from-baseline (BOLD response) | Standard Deviation 0.51 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray | Brain activity - Superior temporal sulcus | -0.48 Change-from-baseline (BOLD response) | Standard Deviation 0.73 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray | Brain activity - Amygdala | 0.03 Change-from-baseline (BOLD response) | Standard Deviation 0.4 |
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)
Time frame: Value at 8 weeks minus value at baseline
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray | Brain activity - Superior temporal sulcus | -0.21 Change-from-baseline (BOLD response) | Standard Deviation 0.58 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray | Brain activity - Amygdala | -0.18 Change-from-baseline (BOLD response) | Standard Deviation 0.52 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray | Brain activity - Superior temporal sulcus | -0.16 Change-from-baseline (BOLD response) | Standard Deviation 0.66 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray | Brain activity - Amygdala | 0.04 Change-from-baseline (BOLD response) | Standard Deviation 0.56 |
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)
Time frame: Value at 30 minutes minus value at baseline
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray | Brain activity - Superior temporal sulcus | 0.11 Change-from-baseline (BOLD response) | Standard Deviation 0.49 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray | Brain activity - Amygdala | -0.15 Change-from-baseline (BOLD response) | Standard Deviation 0.5 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray | Brain activity - Superior temporal sulcus | -0.26 Change-from-baseline (BOLD response) | Standard Deviation 0.72 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray | Brain activity - Amygdala | -0.16 Change-from-baseline (BOLD response) | Standard Deviation 0.58 |
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)
Time frame: Value at 4 weeks minus value at baseline
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray | -0.04 Change-from-base z-transformed r-value | Standard Deviation 0.22 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray | 0.11 Change-from-base z-transformed r-value | Standard Deviation 0.21 |
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)
Time frame: Value at 52 weeks minus value at baseline
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray | -0.06 Change-from-base z-transformed r-value | Standard Deviation 0.2 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray | 0.11 Change-from-base z-transformed r-value | Standard Deviation 0.23 |
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)
Time frame: Value at 8 weeks minus value at baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray | -0.07 Change-from-base z-transformed r-value | Standard Deviation 0.17 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray | 0.13 Change-from-base z-transformed r-value | Standard Deviation 0.18 |
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)
Time frame: Value at 30 minutes minus value at baseline
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray | -0.07 Change-from-base z-transformed r-value | Standard Deviation 0.21 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray | 0.03 Change-from-base z-transformed r-value | Standard Deviation 0.2 |
p-value: <0.08Mixed Models Analysis
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.
Time frame: Value at 4 weeks minus value at baseline
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Depression | -1.14 Change from base (units on a scale) | Standard Deviation 4.5 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SRS-A informant-based | 0.0 Change from base (units on a scale) | Standard Deviation 15.86 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | RBS-R | -4.77 Change from base (units on a scale) | Standard Deviation 6.47 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | IPPA Peers | 1.45 Change from base (units on a scale) | Standard Deviation 3.85 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | IPPA Mother | -0.52 Change from base (units on a scale) | Standard Deviation 2.71 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | WHO-QOL | 1.77 Change from base (units on a scale) | Standard Deviation 8.04 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Vigor | -1.00 Change from base (units on a scale) | Standard Deviation 2.53 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Fatigue | -2.09 Change from base (units on a scale) | Standard Deviation 3.99 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SAAM avoidance | -0.40 Change from base (units on a scale) | Standard Deviation 0.71 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SAAM security | 0.27 Change from base (units on a scale) | Standard Deviation 0.77 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SAAM anxiety | -0.14 Change from base (units on a scale) | Standard Deviation 0.75 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | IPPA Father | 0.43 Change from base (units on a scale) | Standard Deviation 3.3 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Tension | -2.00 Change from base (units on a scale) | Standard Deviation 2.29 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Anger | 0.00 Change from base (units on a scale) | Standard Deviation 4.05 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SRS-A self-report | -5.55 Change from base (units on a scale) | Standard Deviation 11.4 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | IPPA Father | -0.61 Change from base (units on a scale) | Standard Deviation 3.81 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SRS-A self-report | -1.06 Change from base (units on a scale) | Standard Deviation 10.01 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SAAM avoidance | 0.06 Change from base (units on a scale) | Standard Deviation 0.98 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SRS-A informant-based | -0.87 Change from base (units on a scale) | Standard Deviation 12.83 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | WHO-QOL | -1.35 Change from base (units on a scale) | Standard Deviation 6.74 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SAAM security | 0.05 Change from base (units on a scale) | Standard Deviation 0.66 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | IPPA Peers | 0.56 Change from base (units on a scale) | Standard Deviation 4.05 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Anger | -0.61 Change from base (units on a scale) | Standard Deviation 2.73 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SAAM anxiety | 0.28 Change from base (units on a scale) | Standard Deviation 0.95 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Depression | -0.33 Change from base (units on a scale) | Standard Deviation 2.81 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | IPPA Mother | 0.44 Change from base (units on a scale) | Standard Deviation 3.45 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Vigor | -2.94 Change from base (units on a scale) | Standard Deviation 3.64 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Tension | -2.39 Change from base (units on a scale) | Standard Deviation 3.03 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Fatigue | -1.11 Change from base (units on a scale) | Standard Deviation 5.12 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | RBS-R | -1.76 Change from base (units on a scale) | Standard Deviation 4.75 |
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.
Time frame: Value at 52 weeks minus value at baseline
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | RBS-R | -4.91 Change from base (units on a scale) | Standard Deviation 9.46 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Tension | -1.86 Change from base (units on a scale) | Standard Deviation 2.29 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SRS-A informant-based | -7.41 Change from base (units on a scale) | Standard Deviation 19.26 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Anger | 0.59 Change from base (units on a scale) | Standard Deviation 3.69 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Depression | 0.50 Change from base (units on a scale) | Standard Deviation 2.63 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | IPPA Mother | 0.33 Change from base (units on a scale) | Standard Deviation 3.91 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Vigor | 1.14 Change from base (units on a scale) | Standard Deviation 3.88 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SAAM avoidance | -0.52 Change from base (units on a scale) | Standard Deviation 1.18 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Fatigue | -0.23 Change from base (units on a scale) | Standard Deviation 6.04 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | IPPA Father | 0.57 Change from base (units on a scale) | Standard Deviation 4.08 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SAAM security | 0.20 Change from base (units on a scale) | Standard Deviation 1.52 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SAAM anxiety | 0.17 Change from base (units on a scale) | Standard Deviation 0.94 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | IPPA Peers | 0.68 Change from base (units on a scale) | Standard Deviation 6.26 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | WHO-QOL | 1.14 Change from base (units on a scale) | Standard Deviation 8.37 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SRS-A self-report | -8.59 Change from base (units on a scale) | Standard Deviation 20.95 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Fatigue | 0.39 Change from base (units on a scale) | Standard Deviation 4.73 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SRS-A self-report | -6.72 Change from base (units on a scale) | Standard Deviation 21.01 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SRS-A informant-based | -4.13 Change from base (units on a scale) | Standard Deviation 24.64 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | RBS-R | -0.41 Change from base (units on a scale) | Standard Deviation 4.27 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SAAM anxiety | 0.11 Change from base (units on a scale) | Standard Deviation 1.21 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | IPPA Peers | 1.28 Change from base (units on a scale) | Standard Deviation 4.17 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | IPPA Mother | 1.50 Change from base (units on a scale) | Standard Deviation 5.44 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | IPPA Father | -0.50 Change from base (units on a scale) | Standard Deviation 4.53 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | WHO-QOL | 0.29 Change from base (units on a scale) | Standard Deviation 4.21 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Tension | -2.28 Change from base (units on a scale) | Standard Deviation 3.46 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Depression | -0.28 Change from base (units on a scale) | Standard Deviation 3.51 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Vigor | -0.61 Change from base (units on a scale) | Standard Deviation 3.27 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SAAM avoidance | 0.0 Change from base (units on a scale) | Standard Deviation 0.75 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SAAM security | -0.14 Change from base (units on a scale) | Standard Deviation 0.66 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Anger | 0.06 Change from base (units on a scale) | Standard Deviation 3.84 |
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.
Time frame: Value at 8 weeks minus value at baseline
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Depression | -0.82 Change from base (units on a scale) | Standard Deviation 2.63 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | RBS-R | -4.91 Change from base (units on a scale) | Standard Deviation 6.33 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SAAM security | 0.04 Change from base (units on a scale) | Standard Deviation 1.01 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SAAM anxiety | 0.08 Change from base (units on a scale) | Standard Deviation 1.05 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | IPPA Peers | 1.32 Change from base (units on a scale) | Standard Deviation 3.71 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | IPPA Mother | -0.38 Change from base (units on a scale) | Standard Deviation 3.43 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | IPPA Father | 0.52 Change from base (units on a scale) | Standard Deviation 3.59 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | WHO-QOL | 1.14 Change from base (units on a scale) | Standard Deviation 5.48 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Vigor | 0.14 Change from base (units on a scale) | Standard Deviation 3.58 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Fatigue | -2.69 Change from base (units on a scale) | Standard Deviation 2.71 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SRS-A self-report | -5.64 Change from base (units on a scale) | Standard Deviation 12.57 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SAAM avoidance | -0.38 Change from base (units on a scale) | Standard Deviation 0.7 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Tension | -2.64 Change from base (units on a scale) | Standard Deviation 2.8 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | POMS - Anger | 0.36 Change from base (units on a scale) | Standard Deviation 3.68 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | 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 | SRS-A informant-based | -9.59 Change from base (units on a scale) | Standard Deviation 10.98 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Anger | -0.39 Change from base (units on a scale) | Standard Deviation 3.91 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SRS-A informant-based | -1.20 Change from base (units on a scale) | Standard Deviation 10.73 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | WHO-QOL | 0.35 Change from base (units on a scale) | Standard Deviation 4.53 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | RBS-R | -2.35 Change from base (units on a scale) | Standard Deviation 3.43 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SAAM avoidance | -0.06 Change from base (units on a scale) | Standard Deviation 0.76 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Depression | 0.22 Change from base (units on a scale) | Standard Deviation 3.41 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SAAM security | -0.40 Change from base (units on a scale) | Standard Deviation 0.99 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SRS-A self-report | -7.67 Change from base (units on a scale) | Standard Deviation 12.09 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | SAAM anxiety | 0.11 Change from base (units on a scale) | Standard Deviation 0.87 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Vigor | -1.44 Change from base (units on a scale) | Standard Deviation 4.33 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | IPPA Peers | 0.06 Change from base (units on a scale) | Standard Deviation 3.7 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Tension | -2.11 Change from base (units on a scale) | Standard Deviation 3.22 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | IPPA Mother | 0.06 Change from base (units on a scale) | Standard Deviation 4.35 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | POMS - Fatigue | -2.33 Change from base (units on a scale) | Standard Deviation 4.47 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | 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 | IPPA Father | -0.33 Change from base (units on a scale) | Standard Deviation 3.87 |
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.
Time frame: Value at 4 weeks minus value at baseline
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 4 Weeks of Nasal Spray | 0.000044 Change in performance (acc/rt ratio) | Standard Deviation 0.000079 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 4 Weeks of Nasal Spray | 0.000073 Change in performance (acc/rt ratio) | Standard Deviation 0.000071 |
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.
Time frame: Value at 52 weeks minus value at baseline
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 52 Weeks (Including 48 Weeks Without Nasal Spray) | 0.000071 Change in performance (acc/rt ratio) | Standard Deviation 0.000079 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 52 Weeks (Including 48 Weeks Without Nasal Spray) | 0.000084 Change in performance (acc/rt ratio) | Standard Deviation 0.000094 |
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.
Time frame: Value at 8 weeks minus value at baseline
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 8 Weeks (Including 4 Weeks Without Nasal Spray) | 0.000070 Change in performance (acc/rt ratio) | Standard Deviation 0.000084 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 8 Weeks (Including 4 Weeks Without Nasal Spray) | 0.000088 Change in performance (acc/rt ratio) | Standard Deviation 0.000089 |
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.
Time frame: Value at 30 minutes minus value at baseline
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/Reaction Time) After a Single Dose of Nasal Spray | 0.000029 Change in performance (acc/rt ratio) | Standard Deviation 0.000069 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/Reaction Time) After a Single Dose of Nasal Spray | 0.000065 Change in performance (acc/rt ratio) | Standard Deviation 0.000071 |
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.
Time frame: Value at 30 minutes minus value at baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray | POMS - Anger | -0.09 Change from base (units on a scale) | Standard Deviation 2.39 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray | POMS - Vigor | 0.27 Change from base (units on a scale) | Standard Deviation 2.37 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray | POMS - Depression | -0.23 Change from base (units on a scale) | Standard Deviation 1.45 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray | POMS - Fatigue | -1.00 Change from base (units on a scale) | Standard Deviation 2.41 |
| Syntocinon (Oxytocin, Product Code RVG 03716) | Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray | POMS - Tension | -1.59 Change from base (units on a scale) | Standard Deviation 2.11 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray | POMS - Fatigue | -0.72 Change from base (units on a scale) | Standard Deviation 3.68 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray | POMS - Tension | -1.39 Change from base (units on a scale) | Standard Deviation 2.15 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray | POMS - Anger | -0.28 Change from base (units on a scale) | Standard Deviation 0.89 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray | POMS - Depression | -0.67 Change from base (units on a scale) | Standard Deviation 2.25 |
| Placebo (Physiological Water(Sodium Chloride (NaCl) Solution)) | Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray | POMS - Vigor | -0.50 Change from base (units on a scale) | Standard Deviation 2.38 |