Trial · Interventional

CompletedPhase 2Results postedRegistry data

Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors

Short name SOARS-B

NCTNCT01944046Other idPro00063950Other id1U01HD073984Other id13-0593

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 290 participants (actual)
Sponsor: Linmarie Sikich · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 1 Aug 2014
Primary completion: 30 Nov 2017
Completion: 30 Nov 2017
First posted: 17 Sept 2013 (estimated)
Last update posted: 18 Jun 2021
Conditions: Autism Spectrum Disorders

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20142015201620172018

Ph 2
SOARS-B
NCT01944046
1 Aug 2014 to 30 Nov 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this research study is to learn about the effects of supplemental intranasal oxytocin as a treatment for improving social difficulties in children and adolescents with autism. This study will also provide additional information about the safety and tolerability of intranasal oxytocin. Investigators expect oxytocin will increase social motivation, improving daily living skills and quality of life.

Interventions

Double blind phase Placebo Nasal SprayDrug
double Blind Oxytocin Nasal SprayDrug
Open Label intranasal oxytocinDrug

Arms3

Placebo comparator
DB Placebo Nasal Spray
Placebo treatment during weeks 0-24 double blind phase
Active comparator
DB Oxytocin Nasal Spray
DB Oxytocin- quadruply masked treatment with intranasal oxytocin during weeks 0-24 of study during double blind phase of study
Active comparator
open label intranasal oxytocin
non masked treatment with intranasal oxytocin from weeks 24-48 in those participants who completed first 24 weeks of double blind treatment

Primary outcomes2

Outcomes the sponsor listed as primary.

Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity
Time frame · Least Mean Squares Double-blind phase: change from baseline to week 24
Registry description
The primary outcome is Change in Aberrant Behavior Checklist-Modified Social Withdrawal subscale- a measure of reciprocal social behaviors. ABC-mSW is a modification of the ABC-Lethargy subscale. The ABC-mSW consists of the sum of questions 5,12,16, 20, 23, 26, 30, 37, 40, 42, 43, 55, and 58. In contrast to the ABC-Lethargy subscale it eliminates question 3 (listless, sluggish, inactive), question 32 (sits or stands in one position for a long time), and question 53 (inactive, never moves spontaneously). Thirteen individual items are scored 0-3, therefore the range is 0-39. Higher score indicates lower social reciprocity. Repeated measures were obtained at baseline, weeks 4, 8, 12, 16, 20, 24.
Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity
Time frame · Least mean squares for Open Label: Change between weeks 24-48
Registry description
The ABC-mSW is described above and involves 13 items reflecting lack of reciprocal interaction. Each item is scored from 0 (never shows behavior) to 3 (behavior is a major problem). The range is 0-39. Higher scores indicate worse reciprocal social functioning.

Secondary outcomes(3)

Change in Sociability Factor (SF)
Time frame · Double-blind phase: change in least means squares between week 0 & 24.
Registry description
The Sociability Factor (SF) is a summed measure of the13 items of the ABC-SW and the 18 items of the Pervasive Development Disorders Behavior Inventory-Screening Version (PDDBI-SV).The PDDBI-SV assesses both adaptive social behaviors and social problems typical of ASD. The adaptive behaviors are reverse scored so that all the analyzed scores range from 0-performing in a neurotypical fashion to 3 typically performs in a way associated with ASD. the total # of items on this summed measure is 31 with a range from 0 to 93. More impaired social functioning indicated by higher scores. This measure was changed to a secondary outcome in the final statistical analysis plan.
Change in Social Responsiveness Scale-2 (SRS-2) Social Motivation Subscale Score
Time frame · Double-blind phase: baseline, weeks 12, 24
Registry description
The SRS-Social Motivation subscale was developed to provide a quantitative measure of social impairments typically observed in ASD in children 3-18 years. Reported as T-score with a range of 38-90 for both boys and girls. Higher score indicates more severe clinical condition. Lower value in change indicates more improvement.
Change in Stanford Binet-5th Edition (SB-5) IQ Score
Time frame · Double-blind phase: baseline to week 24
Registry description
Cognitive skills will be assessed using the Stanford Binet-5th Edition (SB-5) (Roid). Acceptable IQ range is 47-153, with higher score being better. Higher change scores indicate more improvement.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Least Mean Squares Double-blind phase: change from baseline to week 24

Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity

Group	Value (score on a scale)	Spread
Oxytocin Nasal Spray	8.81	0.39
Placebo Nasal Spray	8.68	0.39

Primary outcomeLeast squares mean· Least mean squares for Open Label: Change between weeks 24-48

Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity

Group	Value (score on a scale)
Oxytocin Nasal Spray	7.83
Placebo Nasal Spray	7.81

Secondary and other outcome results(6)

Secondary outcomeLeast squares mean· Double-blind phase: change in least means squares between week 0 & 24.

Change in Sociability Factor (SF)

Group	Value (score on a scale)	Spread
Oxytocin Nasal Spray	35.8	1.24
Placebo Nasal Spray	36.1	1.28

Secondary outcomeMean· Double-blind phase: baseline, weeks 12, 24

Change in Social Responsiveness Scale-2 (SRS-2) Social Motivation Subscale Score

Group	Value (T-score)	Spread
Oxytocin Nasal Spray	-4.58	0.68
Placebo Nasal Spray	-5.72	0.69

Secondary outcomeMean· Double-blind phase: baseline to week 24

Change in Stanford Binet-5th Edition (SB-5) IQ Score

Group	Value (score on a scale)	Spread
Oxytocin Nasal Spray	0.40	11.64
Placebo Nasal Spray	1.0	10.84

Other pre specified outcomeMean· Open Label: weeks 24, 48

Social Responsiveness Scale-2 (SRS-2) Social Motivation Subscale Score

Group	Value (T-score)	Spread
Oxytocin Nasal Spray	88.5	1.37
Placebo Nasal Spray	86.6	1.37

Other pre specified outcomeMean· Double-blind phase: baseline, week 24; Open Label: week 48

Change in Vineland II Adaptive Behavior Scales (VABS-II) Daily Living Domain Score

Group	Value (score on a scale)	Spread
Oxytocin Nasal Spray	2.50	1.10
Placebo Nasal Spray	1.24	1.14

Other pre specified outcomeMean· Open Label: weeks 24, 48

Caregiver Strain Questionnaire (CSQ) Subjective Internalizing Subscale Mean Score

Group	Value (mean score on a scale)	Spread
Oxytocin Nasal Spray	2.96	0.99
Placebo Nasal Spray	2.85	1.00

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Oxytocin Nasal Spray: Double-blind PhaseOxytocin Oxytocin Nasal Spray: Each insufflation will deliver 8 IU or 24 IU of oxytocin. A maximum of 3 insufflations at a time will be required. Dosing will be flexible between 8 IU/day and 80 IU/day, typically in two divided doses delivered in the morning and in the afternoon. Doses will typically increase by 8 IU twice daily (BID) at week 2 and weeks 4 and 8 until achieving the target dose of 24 IU BID at week 8. Subsequently doses may be increased in 8 IU BID increments ONLY at each visit until a maximum dose of 40 IU BID is achieved.Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. During the open label phase after approximately March 2019 the study used only the 24 IU /0.10 ml formulation and the maximum dose was 72 IU per day.	0 / 146	2 / 146	120 / 146
Placebo Nasal Spray: Double-blind PhasePlacebo Placebo Nasal Spray: This nasal spray will contain all of the ingredients that are in the active oxytocin spray in the same quantities, except there will be no oxytocin added to the solution. It will be packaged using the same container system as the active oxytocin nasal spray. Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. Dose titration will occur using exactly the same criteria and procedures as for active study drug.	0 / 144	1 / 144	120 / 144
Oxytocin Nasal Spray: Open Label PhaseOxytocin Oxytocin Nasal Spray: Each insufflation will deliver 8 IU or 24 IU of oxytocin. A maximum of 3 insufflations at a time will be required. Dosing will be flexible between 8 IU/day and 80 IU/day, typically in two divided doses delivered in the morning and in the afternoon. Doses will typically increase by 8 IU twice daily (BID) at week 2 and weeks 4 and 8 until achieving the target dose of 24 IU BID at week 8. Subsequently doses may be increased in 8 IU BID increments ONLY at each visit until a maximum dose of 40 IU BID is achieved.Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. During the open label phase after approximately March 2019 the study used only the 24 IU /0.10 ml formulation and the maximum dose was 72 IU per day.	1 / 127	4 / 127	91 / 127
Placebo Nasal Spray: Open Label PhasePlacebo Placebo Nasal Spray: This nasal spray will contain all of the ingredients that are in the active oxytocin spray in the same quantities, except there will be no oxytocin added to the solution. It will be packaged using the same container system as the active oxytocin nasal spray. Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. Dose titration will occur using exactly the same criteria and procedures as for active study drug.	0 / 122	0 / 122	92 / 122

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

3 results

Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder.

Sikich et al. 2021The New England journal of medicinecited by 211

PMID 34644471PMC9701092DOI 10.1056/nejmoa2103583PUB-34644471

Rights unknown3 results

Source link See results (3)

More studies

1 study on this page

PubMed tag: none · 2020

Rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).

Spanos et al. 2020Contemporary clinical trialscited by 14

PMID 32777383PMC7924986DOI 10.1016/j.cct.2020.106103PUB-32777383

Free to read · publisher termsCC BY-NC-ND

Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedIffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2. PMID 37811711

Eligibility

Who could join, as posted.

Sex: All
Age: from 3 Years up to 17 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Be between the ages of 3 years 0 months and 17 years 11 months at the time of randomization * Be diagnosed by clinician experienced in assessment of ASD with autistic disorder, Asperger's syndrome, or PDD-NOS using DSM-V-TR criteria * Must have clinical diagnosis of ASD confirmed using the Autism Diagnostic Observation Scale (ADOS, Lord et al., 2001) * Must have clinical diagnosis of ASD confirmed using the Autism Diagnostic Interview-Revised (ADI-R, Rutter, 2003). ASD criteria proposed by Risi (2006). Specifically, subject must be within 1 point of autism criteria on both social and communication domains of the ADI or meet autism criteria in one of these ADI domains and come within 2 points of autism criteria in the other * Have a guardian who is able to provide informed consent * If cognitively able, subject must be able to provide informed assent/consent Exclusion Criteria: * Have a known diagnosis of Rett Syndrome or Childhood Disintegrative Disorder, or have marked sensory impairment such as deafness or blindness * Have active cardiovascular disease or renal disease that is not controlled by medication * Subjects who are pregnant, lactating, or who refuse to practice contraception if sexually active * Subjects who have had changes in allied health therapies, behavioral or educational interventions within the two months prior to randomization other than those associated with school holidays * Subjects who have had changes in psychiatric medications within 4 weeks of randomization * Subjects who have had previous chronic treatment with oxytocin * Subjects who have caretakers who are unable to speak English, be consistently present at visits to report on symptoms, or are otherwise judged as unable to comply with the protocol by the data collection site team * Subjects with active seizures within the 6 months preceding screening or baseline -added part way through study in response to subject death.

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