Hyperphagia, Prader-Willi Syndrome
Conditions
Keywords
Prader-Willi Syndrome (PWS), Hyperphagia
Brief summary
The investigators propose a randomized double-blind 8 week treatment trial of intranasal oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels.
Detailed description
The investigators propose to conduct a treatment study of intranasal oxytocin (IN-OXT) vs. placebo in children and adolescents with Prader-Willi Syndrome (PWS). OXT has already been proven safe and effective in a treatment study of socialization and disruptive behavior in adults with PWS and is being used in infants with PWS in an ongoing clinical trial. The investigators hypothesize that OXT will be superior to placebo and have a positive effect on child and adolescent PWS eating and repetitive behaviors. Additional knowledge of OXT's ability to reduce overeating could lead to improvement of patient's quality of life and physical health and reduction in familial stress. The investigators propose a randomized double-blind 8 week treatment trial of intranasal OXT vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels. If superior to placebo, this data will add to the current knowledge that OXT is an effective treatment for hyperphagia as well as other problematic symptomatology of PWS.
Interventions
Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
OTHERMatched Placebo
Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
Sponsors
Foundation for Prader-Willi Research
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Male or Female child outpatients aged 5 to 18 years 2. Diagnosis of PWS confirmed by genetic testing and patient medical records and history 3. Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks prior to the study start, and for the duration of the study. 4. Have a physical exam and laboratory results that are within the norms for PWS 5. Have a parent/caregiver/guardian that is able to consent for their participation and complete assessments regarding the child's development and behavior improvement throughout the study.
Exclusion criteria
1. Exposure to any investigational agent in the 30 days prior to randomization 2. Prior chronic treatment with oxytocin. 3. A primary psychiatric diagnosis other than ASD, including bipolar disorder, psychosis, schizophrenia, PTSD or major depressive disorder. These patients will be excluded due to potential confounding results. 4. Pregnant or lactating patients. IN-OXT has not been studied in pregnant or lactating women. 5. A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger their own well-being. 6. Plan to initiate or change nonpharmacologic or pharmacologic interventions during the course of the study. 7. Females using an estrogen-based contraceptive. As an alternative to an estrogen based contraceptive, subjects will be counseled to use progesterone-based contraceptives; cervical caps; cervical sponges; or spermicidal foam in combination with a condom. Subjects will need to use a double barrier method to be in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hyperphagia Questionnaire (HQ)- Total Score | Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported. | The Hyperphagia Questionnaire (HQ)- Total Score. The HQ is a 11-item clinician-rated instrument that was designed to measure food related behaviors in PWS. Items map onto 3 subscales; Hyperphagic Behavior, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome. |
| Hyperphagia Questionnaire (HQ)- Behavior Factor Score | Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported. | The Hyperphagia Questionnaire (HQ)- Behavior Factor Score assesses food seeking behaviors (e.g., stealing food). The Behavior Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviors and a worse outcome. |
| Hyperphagia Questionnaire (HQ)- Drive Factor Score | Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported. | The Hyperphagia Questionnaire (HQ)- Drive Factor Score assesses the persistence in asking for food. The Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome |
| Hyperphagia Questionnaire (HQ) -Severity Factor Score | Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported. | The Hyperphagia Questionnaire (HQ)- Severity Factor Score assesses the severity of hyperphagia. The Severity Factor Score ranges from 2-10, with higher scores indicating higher severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Repetitive Behavior Scale-Revised (RBS-R) Self-Injurious Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | The Repetitive Behavior Scale-Revised (RBS-R) Self-Injurious Factor Score assesses self-injurious behaviors. Scores range from 0-24, with higher scores indicating more self-injurious behaviors and a worse outcome. |
| Repetitive Behavior Scale-Revised (RBS-R) Ritualistic Behavior Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | The Repetitive Behavior Scale-Revised (RBS-R) Ritualistic Behavior Factor Score assesses ritualistic behaviors. Scores range from 0-18, with higher scores indicating more ritualistic behaviors and a worse outcome. |
| Repetitive Behavior Scale-Revised (RBS-R) Restricted Interest Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | The Repetitive Behavior Scale-Revised (RBS-R) Restricted Interest Factor Score assesses restricted interests. Scores range from 0-12, with higher scores indicating more restricted interests and a worse outcome. |
| Repetitive Behavior Scale-Revised (RBS-R) Sameness Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | The Repetitive Behavior Scale-Revised (RBS-R) Sameness Factor Score assesses the need for sameness in the environment. Scores range from 0-33, with higher scores indicating more need for sameness and a worse outcome. |
| Repetitive Behavior Scale-Revised (RBS-R) Stereotyped Behavior Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | The Repetitive Behavior Scale-Revised (RBS-R) Stereotyped Behavior Factor Score assesses stereotyped behaviors. Scores range from 0-18, with higher scores indicating more stereotyped behaviors and a worse outcome. |
| Repetitive Behavior Scale-Revised (RBS-R) Compulsive Behavior Factor Score | Trends over multiple time points (Weeks 0, 4, and 8). | The Repetitive Behavior Scale-Revised (RBS-R) Compulsive Behavior Factor Score assesses compulsive behaviors. Scores range from 0-24, with higher scores indicating more compulsive behaviors and a worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Oxytocin Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff). | 11 |
| Matched Placebo Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff). | 12 |
| Total | 23 |
Baseline characteristics
| Characteristic | Matched Placebo | Total | Intranasal Oxytocin |
|---|---|---|---|
| Age, Continuous | 8.08 years STANDARD_DEVIATION 3.82 | 8.87 years STANDARD_DEVIATION 3.68 | 9.72 years STANDARD_DEVIATION 3.5 |
| Baseline BMI | 21.2 kg/m^2 STANDARD_DEVIATION 6.05 | 20.92 kg/m^2 STANDARD_DEVIATION 5.47 | 20.61 kg/m^2 STANDARD_DEVIATION 5.04 |
| Baseline Height (cm) | 124.91 cm STANDARD_DEVIATION 31.71 | 132.92 cm STANDARD_DEVIATION 26.11 | 141.65 cm STANDARD_DEVIATION 15.23 |
| Baseline Weight (kg) | 38.53 kg STANDARD_DEVIATION 20.97 | 40.25 kg STANDARD_DEVIATION 17.89 | 42.13 kg STANDARD_DEVIATION 14.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 17 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Hyperphagia Questionnaire (HQ)-Total | 30.58 score on a scale STANDARD_DEVIATION 8.08 | 29.3 score on a scale STANDARD_DEVIATION 9.34 | 27.91 score on a scale STANDARD_DEVIATION 10.77 |
| 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 | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 8 Participants | 17 Participants | 9 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 9 Participants | 18 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 7 / 11 | 7 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 |
Outcome results
Primary
Hyperphagia Questionnaire (HQ)- Behavior Factor Score
The Hyperphagia Questionnaire (HQ)- Behavior Factor Score assesses food seeking behaviors (e.g., stealing food). The Behavior Factor Score ranges from 5-25, with higher scores indicating more hyperphagic behaviors and a worse outcome.
Time frame: Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported.
Population: 1 subject discontinued oxytocin early and 1 subject discontinued placebo early
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Oxytocin | Hyperphagia Questionnaire (HQ)- Behavior Factor Score | Baseline | 9.55 score on a scale | Standard Deviation 5.01 |
| Intranasal Oxytocin | Hyperphagia Questionnaire (HQ)- Behavior Factor Score | Week 4 | 9.4 score on a scale | Standard Deviation 4.27 |
| Intranasal Oxytocin | Hyperphagia Questionnaire (HQ)- Behavior Factor Score | Week 8 | 9.64 score on a scale | Standard Deviation 4.9 |
| Matched Placebo | Hyperphagia Questionnaire (HQ)- Behavior Factor Score | Baseline | 9.75 score on a scale | Standard Deviation 3.47 |
| Matched Placebo | Hyperphagia Questionnaire (HQ)- Behavior Factor Score | Week 4 | 7.22 score on a scale | Standard Deviation 2.64 |
| Matched Placebo | Hyperphagia Questionnaire (HQ)- Behavior Factor Score | Week 8 | 8.09 score on a scale | Standard Deviation 4.25 |
p-value: 0.088Mixed effects model
Primary
Hyperphagia Questionnaire (HQ)- Drive Factor Score
The Hyperphagia Questionnaire (HQ)- Drive Factor Score assesses the persistence in asking for food. The Drive Factor Score ranges from 4-20, with higher scores indicating higher hyperphagic drive and a worse outcome
Time frame: Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported.
Population: 1 subject discontinued oxytocin early and 1 subject discontinued placebo early
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Oxytocin | Hyperphagia Questionnaire (HQ)- Drive Factor Score | Baseline | 10.82 score on a scale | Standard Deviation 4.81 |
| Intranasal Oxytocin | Hyperphagia Questionnaire (HQ)- Drive Factor Score | Week 4 | 11 score on a scale | Standard Deviation 4.03 |
| Intranasal Oxytocin | Hyperphagia Questionnaire (HQ)- Drive Factor Score | Week 8 | 10.36 score on a scale | Standard Deviation 4.84 |
| Matched Placebo | Hyperphagia Questionnaire (HQ)- Drive Factor Score | Baseline | 13.58 score on a scale | Standard Deviation 4.44 |
| Matched Placebo | Hyperphagia Questionnaire (HQ)- Drive Factor Score | Week 4 | 10.44 score on a scale | Standard Deviation 5.46 |
| Matched Placebo | Hyperphagia Questionnaire (HQ)- Drive Factor Score | Week 8 | 10.55 score on a scale | Standard Deviation 4.48 |
p-value: 0.027Mixed effects model
Primary
Hyperphagia Questionnaire (HQ) -Severity Factor Score
The Hyperphagia Questionnaire (HQ)- Severity Factor Score assesses the severity of hyperphagia. The Severity Factor Score ranges from 2-10, with higher scores indicating higher severity.
Time frame: Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported.
Population: 1 subject discontinued oxytocin early and 1 subject discontinued placebo early
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Oxytocin | Hyperphagia Questionnaire (HQ) -Severity Factor Score | Baseline | 7.55 score on a scale | Standard Deviation 2.62 |
| Intranasal Oxytocin | Hyperphagia Questionnaire (HQ) -Severity Factor Score | Week 4 | 7.00 score on a scale | Standard Deviation 2.54 |
| Intranasal Oxytocin | Hyperphagia Questionnaire (HQ) -Severity Factor Score | Week 8 | 6.91 score on a scale | Standard Deviation 2.74 |
| Matched Placebo | Hyperphagia Questionnaire (HQ) -Severity Factor Score | Baseline | 7.25 score on a scale | Standard Deviation 2.09 |
| Matched Placebo | Hyperphagia Questionnaire (HQ) -Severity Factor Score | Week 4 | 5.67 score on a scale | Standard Deviation 2.45 |
| Matched Placebo | Hyperphagia Questionnaire (HQ) -Severity Factor Score | Week 8 | 6.45 score on a scale | Standard Deviation 2.54 |
p-value: 0.16Mixed effects model
Primary
Hyperphagia Questionnaire (HQ)- Total Score
The Hyperphagia Questionnaire (HQ)- Total Score. The HQ is a 11-item clinician-rated instrument that was designed to measure food related behaviors in PWS. Items map onto 3 subscales; Hyperphagic Behavior, Hyperphagic Drive, and Hyperphagia Severity. The subscales are summed together to compute the Total Score. The Total Score ranges from 11-55, with higher scores indicating more hyperphagia and a worse outcome.
Time frame: Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported.
Population: 1 subject discontinued oxytocin early and 1 subject discontinued placebo early
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Oxytocin | Hyperphagia Questionnaire (HQ)- Total Score | Baseline | 27.91 score on a scale | Standard Deviation 10.77 |
| Intranasal Oxytocin | Hyperphagia Questionnaire (HQ)- Total Score | Week 4 | 27.4 score on a scale | Standard Deviation 9.85 |
| Intranasal Oxytocin | Hyperphagia Questionnaire (HQ)- Total Score | Week 8 | 26.91 score on a scale | Standard Deviation 11.67 |
| Matched Placebo | Hyperphagia Questionnaire (HQ)- Total Score | Baseline | 30.58 score on a scale | Standard Deviation 8.08 |
| Matched Placebo | Hyperphagia Questionnaire (HQ)- Total Score | Week 4 | 23.33 score on a scale | Standard Deviation 8.41 |
| Matched Placebo | Hyperphagia Questionnaire (HQ)- Total Score | Week 8 | 25.09 score on a scale | Standard Deviation 9.86 |
p-value: 0.059Mixed effects model
Secondary
Repetitive Behavior Scale-Revised (RBS-R) Compulsive Behavior Factor Score
The Repetitive Behavior Scale-Revised (RBS-R) Compulsive Behavior Factor Score assesses compulsive behaviors. Scores range from 0-24, with higher scores indicating more compulsive behaviors and a worse outcome.
Time frame: Trends over multiple time points (Weeks 0, 4, and 8).
Population: 1 subject discontinued oxytocin early and 1 subject discontinued placebo early
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Compulsive Behavior Factor Score | Baseline | 5.18 score on a scale | Standard Deviation 6.9 |
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Compulsive Behavior Factor Score | Week 4 | 4.9 score on a scale | Standard Deviation 5.69 |
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Compulsive Behavior Factor Score | Week 8 | 4.5 score on a scale | Standard Deviation 5.99 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Compulsive Behavior Factor Score | Baseline | 7.5 score on a scale | Standard Deviation 4.89 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Compulsive Behavior Factor Score | Week 4 | 5.27 score on a scale | Standard Deviation 5.24 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Compulsive Behavior Factor Score | Week 8 | 5.09 score on a scale | Standard Deviation 5.41 |
p-value: 0.033Mixed effects model
Secondary
Repetitive Behavior Scale-Revised (RBS-R) Restricted Interest Factor Score
The Repetitive Behavior Scale-Revised (RBS-R) Restricted Interest Factor Score assesses restricted interests. Scores range from 0-12, with higher scores indicating more restricted interests and a worse outcome.
Time frame: Trends over multiple time points (Weeks 0, 4, and 8).
Population: 1 subject discontinued oxytocin early and 1 subject discontinued placebo early
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Restricted Interest Factor Score | Baseline | 3.27 score on a scale | Standard Error 3.55 |
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Restricted Interest Factor Score | Week 4 | 2.20 score on a scale | Standard Error 1.81 |
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Restricted Interest Factor Score | Week 8 | 2.10 score on a scale | Standard Error 2.13 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Restricted Interest Factor Score | Baseline | 5.17 score on a scale | Standard Error 3.27 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Restricted Interest Factor Score | Week 4 | 4.00 score on a scale | Standard Error 3.13 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Restricted Interest Factor Score | Week 8 | 3.73 score on a scale | Standard Error 3.82 |
p-value: 0.53Mixed effects model
Secondary
Repetitive Behavior Scale-Revised (RBS-R) Ritualistic Behavior Factor Score
The Repetitive Behavior Scale-Revised (RBS-R) Ritualistic Behavior Factor Score assesses ritualistic behaviors. Scores range from 0-18, with higher scores indicating more ritualistic behaviors and a worse outcome.
Time frame: Trends over multiple time points (Weeks 0, 4, and 8).
Population: 1 subject discontinued oxytocin early and 1 subject discontinued placebo early
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Ritualistic Behavior Factor Score | Baseline | 6.27 score on a scale | Standard Error 3.74 |
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Ritualistic Behavior Factor Score | Week 4 | 4.50 score on a scale | Standard Error 3.84 |
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Ritualistic Behavior Factor Score | Week 8 | 4.90 score on a scale | Standard Error 3.73 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Ritualistic Behavior Factor Score | Baseline | 9.42 score on a scale | Standard Error 5 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Ritualistic Behavior Factor Score | Week 4 | 6.27 score on a scale | Standard Error 3.77 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Ritualistic Behavior Factor Score | Week 8 | 6.64 score on a scale | Standard Error 4.65 |
p-value: 0.69Mixed effects model
Secondary
Repetitive Behavior Scale-Revised (RBS-R) Sameness Factor Score
The Repetitive Behavior Scale-Revised (RBS-R) Sameness Factor Score assesses the need for sameness in the environment. Scores range from 0-33, with higher scores indicating more need for sameness and a worse outcome.
Time frame: Trends over multiple time points (Weeks 0, 4, and 8).
Population: 1 subject discontinued oxytocin early and 1 subject discontinued placebo early
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Sameness Factor Score | Baseline | 9.36 score on a scale | Standard Deviation 4.72 |
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Sameness Factor Score | Week 4 | 6.6 score on a scale | Standard Deviation 5.25 |
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Sameness Factor Score | Week 8 | 7.3 score on a scale | Standard Deviation 5.17 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Sameness Factor Score | Baseline | 14.17 score on a scale | Standard Deviation 8.07 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Sameness Factor Score | Week 4 | 8 score on a scale | Standard Deviation 6.6 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Sameness Factor Score | Week 8 | 7.55 score on a scale | Standard Deviation 7.39 |
p-value: 0.034Mixed effects model
Secondary
Repetitive Behavior Scale-Revised (RBS-R) Self-Injurious Factor Score
The Repetitive Behavior Scale-Revised (RBS-R) Self-Injurious Factor Score assesses self-injurious behaviors. Scores range from 0-24, with higher scores indicating more self-injurious behaviors and a worse outcome.
Time frame: Trends over multiple time points (Weeks 0, 4, and 8).
Population: 1 subject discontinued oxytocin early and 1 subject discontinued placebo early
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Self-Injurious Factor Score | Baseline | 5.00 score on a scale | Standard Deviation 2.97 |
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Self-Injurious Factor Score | Week 4 | 4.40 score on a scale | Standard Deviation 2.76 |
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Self-Injurious Factor Score | Week 8 | 4.40 score on a scale | Standard Deviation 2.46 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Self-Injurious Factor Score | Baseline | 2.82 score on a scale | Standard Deviation 2.86 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Self-Injurious Factor Score | Week 4 | 3.45 score on a scale | Standard Deviation 5.68 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Self-Injurious Factor Score | Week 8 | 3.36 score on a scale | Standard Deviation 5.78 |
p-value: 0.78Mixed effects model
Secondary
Repetitive Behavior Scale-Revised (RBS-R) Stereotyped Behavior Factor Score
The Repetitive Behavior Scale-Revised (RBS-R) Stereotyped Behavior Factor Score assesses stereotyped behaviors. Scores range from 0-18, with higher scores indicating more stereotyped behaviors and a worse outcome.
Time frame: Trends over multiple time points (Weeks 0, 4, and 8).
Population: 1 subject discontinued oxytocin early and 1 subject discontinued placebo early
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Stereotyped Behavior Factor Score | Baseline | 2.18 score on a scale | Standard Deviation 2.52 |
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Stereotyped Behavior Factor Score | Week 4 | 2.5 score on a scale | Standard Deviation 3.76 |
| Intranasal Oxytocin | Repetitive Behavior Scale-Revised (RBS-R) Stereotyped Behavior Factor Score | Week 8 | 2.2 score on a scale | Standard Deviation 3.01 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Stereotyped Behavior Factor Score | Baseline | 3.33 score on a scale | Standard Deviation 2.84 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Stereotyped Behavior Factor Score | Week 4 | 2 score on a scale | Standard Deviation 2.53 |
| Matched Placebo | Repetitive Behavior Scale-Revised (RBS-R) Stereotyped Behavior Factor Score | Week 8 | 1.09 score on a scale | Standard Deviation 1.58 |
p-value: 0.009Mixed effects model