Prader-Willi SyndromeOxyjeuneNCT03114371

Oxytocin Intranasal Administrations in Children With Prader-Willi Syndrome Aged From 3 to 12 Years

A study testing Oxytocin in people with Prader-Willi Syndrome, run by University Hospital, Toulouse at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 3 to 12 years
Conditions the study is for: Prader-Willi Syndrome
What is being tested?: Oxytocin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteFrance
Study dates: 28 Nov 2016to 11 Jan 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

patient with a complete genetic diagnosis of Prader-Willi syndrome
patient treated by growth hormone for at least 1 year
patient naïve for oxytocin for at least 5 years

Who cannot join

patient who do not accept intranasal administrations (major behavioural trouble)
patient with hepatic insufficiency : serum transaminases (SGOT, SGPT) higher than 3 times normal values for age
patient with renal insufficiency : serum creatinine higher than 3 times normal values for age
patient with an antecedent of abnormal electrocardiogram
patient with arterial hypertension or hypotension
patient with type 1 or 2 diabetes

Trial locations and contacts

1 site in 1 country.

France1 site

Centre de référence du syndrome de Prader-Willi Hôpital des Enfants
Toulouse, 31059

Other trials in France

About this study

Official title: Effects of Intranasal Administrations of Oxytocin on Behavioural Troubles, Hyperphagia and Social Skills in Children With Prader-Willi Syndrome Aged From 3 to 12 Years.

Positive results in preclinical and clinical studies in adults and infants with Prader-Willi syndrome lead investigators to set up a new study in children with Prader-Willi syndrome. The objective of this study is to document effects of oxytocin intranasal administrations on behavioural troubles in children with Prader-Willi syndrome aged from 3 to 12 years.

Read the detailed description

Two groups of patients will be constituted according to their age; "Group 1" children aged from 3 to 6 years (n = 20) and "Group 2" children aged from 7 to 12 years (n = 20). Within each group, subjects will be randomized to receive either oxytocin or placebo for 12 consecutive weeks. A second period of 12 consecutive oxytocin treatment weeks will then be performed for all patients, followed by a 4-week observation period to document effects after discontinuation of treatment.

Conditions: Prader-Willi Syndrome
Being tested: Oxytocin, Placebo
Keywords: Prader-Willi syndrome, Oxytocin, Behavioural troubles
Medical subject headings: Prader-Willi Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxytocinDrug
Also called Intranasal administration of oxytocin (Week 1 to 12)
The study drug is oxytocin in intra-nasal administration, Syntocinon®, reconditioned as a placebo-like spray. The dosage administered will be 8 International Unit, ie 1 spray (4 International Unit per spray) in each nostril per day for the first 12 weeks, in 3 and 6 years old patients. The dosage administered will be 16 International Unit or 2 sprays in each nostril per day for the first 12 weeks, in 3 to 6 years old patients.
PlaceboDrug
Also called Intranasal administration of placebo (Week 1 to 12)
Placebo should be used as a spray, similar to that of the oxytocin. The dosage administered will be 1 spray in each nostril per day for the first 12 weeks in 3 to 6 years old patients. The dosage administered will be 2 sprays in each nostril per day for the first 12 weeks, in 7 to 12 years old patients.
OxytocinDrug
Also called Intranasal administration of oxytocin (Week 13 to 24)
Each patient will receive oxytocin in open label (Syntocinon® not reconditioned) from week 13 to week 24 according to the same dosages.

Study groups in NCT03114371
Study group	Role	What they receive
Oxytocin	Experimental	Daily intranasal administrations of oxytocin for 12 weeks, followed by an open-label period of 12 weeks of oxytocin. Oxytocin dose will be 8 International Unit for patients aged from 3 to 6 years and 16 International Unit for patients aged from 7 to 12 years. Receives: Drug: Oxytocin
Placebo	Placebo comparator	Daily intranasal administrations of placebo for 12 weeks, followed by an open-label period of 12 weeks of oxytocin. Oxytocin dose will be International Unit for patients aged from 3 to 6 years and 16 International Unit for patients aged from 7 to 12 years. Receives: Drug: Placebo; Drug: Oxytocin

What is being measured

The primary outcome is the main question the study is designed to answer.

Evolution of behavioural troubles evaluated by the global score of Child Behavior Check List Questionnaire after 12 weeks of oxytocin/placebo treatment.
It's variation between inclusion and 12 weeks of total score total problems from the Child Behavior Check List Questionnaire.
Measured: Week 12

Secondary outcomes (8)

Evaluation of hyperphagia after 12 weeks of oxytocin/placebo treatment.
It is the variation of each of the three sub-scores obtained from the Dykens hyperphagia questionnaire between day 0 and week 12.
Measured: Week 12
Evaluation of social skills after 12 weeks of oxytocin/placebo treatment.
It is variation between day 0 and week 12 of the total score obtained from the social skills assessment questionnaire for children aged from 3 to 6 years and the Social Responsiveness Scale questionnaire for children aged from 7 to 12 years.
Measured: Week 12
Evaluation of auto- and hetero-aggressive after 12 weeks of oxytocin/placebo treatment.
It is variation between day 0 and week 12 of the total score obtained from the self-aggression assessment questionnaire.
Measured: Week 12
Evaluation of psychopathology after 12 weeks of oxytocin/placebo treatment.
It is the variation of the following sub-scores obtained from the Child Behaviour Check List questionnaire (only the following 3 subscales) between day 0 and week 12.
Measured: Week 12
Evaluation of global clinical status after 12 weeks of oxytocin/placebo treatment.
It is improvement of the patient's overall clinical condition after 12 weeks of treatment with oxytocin/placebo. It's assessed by the Clinical Global Impression Scale's score.
This scale of improvement of Clinical Global Impression is a 7-point ordinal qualitative scale of "very greatly improved" rated + 3 to "very strongly aggravated" rated -3. The result is expressed in total score which varies from -3 to +3.
Measured: Weeks 12
Evaluation of acyl and desacyl ghrelin plasma levels after 12 weeks of oxytocin/placebo treatment.
It is evolution of circulating levels of acylated and deacylated ghrelin will be the variations of these rates and the variation of the relationships between day 0 and week 12.
Measured: Week 12
Evaluation of attentional abilities after 12 weeks of oxytocin/placebo treatment, for patients aged from 7 to 12 years at inclusion.
It is evolution of attentional abilities is evaluated by a computerized test, the Attention Network Test.
Measured: Week 12
Evaluation of metabolic brain resting state after 12 weeks of oxytocin/placebo treatment, for patients aged from 7 to 12 years at inclusion.
It is evolution of metabolic brain resting state is evaluated by a magnetic resonance imaging to study the cerebral metabolism between day 0 and week 12.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Nov 201611 Jan 2019

First posted14 Apr 2017
Study start28 Nov 2016
Primary completionJan 2019
Study completion11 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Children will receive after randomization either placebo or oxytocin administration (daily intranasal) for a total duration of 12 consecutive weeks.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03114371
Sponsor's protocol ID: 15 7837 03
Other IDs: 2016-003273-18, 2016
Acronym: Oxyjeune
Status last verified: Nov 2020
First submitted: 10 Mar 2017
Last updated: 12 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bittel DC, Kibiryeva N, Sell SM, Strong TV, Butler MG. Whole genome microarray analysis of gene expression in Prader-Willi syndrome. Am J Med Genet A. 2007 Mar 1;143A(5):430-42. doi: 10.1002/ajmg.a.31606.
PubMed 17236194
Constantino JN, Todd RD. Intergenerational transmission of subthreshold autistic traits in the general population. Biol Psychiatry. 2005 Mar 15;57(6):655-60. doi: 10.1016/j.biopsych.2004.12.014.
PubMed 15780853
Dykens EM, Lee E, Roof E. Prader-Willi syndrome and autism spectrum disorders: an evolving story. J Neurodev Disord. 2011 Sep;3(3):225-37. doi: 10.1007/s11689-011-9092-5. Epub 2011 Aug 20.
PubMed 21858456
Dykens EM, Maxwell MA, Pantino E, Kossler R, Roof E. Assessment of hyperphagia in Prader-Willi syndrome. Obesity (Silver Spring). 2007 Jul;15(7):1816-26. doi: 10.1038/oby.2007.216.
PubMed 17636101
Dykens E, Schwenk K, Maxwell M, Myatt B. The Sentence Completion and Three Wishes tasks: windows into the inner lives of people with intellectual disabilities. J Intellect Disabil Res. 2007 Aug;51(Pt 8):588-97. doi: 10.1111/j.1365-2788.2006.00937.x.
PubMed 17598872
Einfeld SL, Smith E, McGregor IS, Steinbeck K, Taffe J, Rice LJ, Horstead SK, Rogers N, Hodge MA, Guastella AJ. A double-blind randomized controlled trial of oxytocin nasal spray in Prader Willi syndrome. Am J Med Genet A. 2014 Sep;164A(9):2232-9. doi: 10.1002/ajmg.a.36653. Epub 2014 Jun 30.
PubMed 24980612
Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886.
PubMed 11970796
Goldstone AP, Holland AJ, Butler JV, Whittington JE. Appetite hormones and the transition to hyperphagia in children with Prader-Willi syndrome. Int J Obes (Lond). 2012 Dec;36(12):1564-70. doi: 10.1038/ijo.2011.274. Epub 2012 Jan 24.
PubMed 22270375
Guastella AJ, Einfeld SL, Gray KM, Rinehart NJ, Tonge BJ, Lambert TJ, Hickie IB. Intranasal oxytocin improves emotion recognition for youth with autism spectrum disorders. Biol Psychiatry. 2010 Apr 1;67(7):692-4. doi: 10.1016/j.biopsych.2009.09.020. Epub 2009 Nov 7.
PubMed 19897177
Guastella AJ, Gray KM, Rinehart NJ, Alvares GA, Tonge BJ, Hickie IB, Keating CM, Cacciotti-Saija C, Einfeld SL. The effects of a course of intranasal oxytocin on social behaviors in youth diagnosed with autism spectrum disorders: a randomized controlled trial. J Child Psychol Psychiatry. 2015 Apr;56(4):444-52. doi: 10.1111/jcpp.12305. Epub 2014 Aug 2.
PubMed 25087908
Hall SS, Lightbody AA, McCarthy BE, Parker KJ, Reiss AL. Effects of intranasal oxytocin on social anxiety in males with fragile X syndrome. Psychoneuroendocrinology. 2012 Apr;37(4):509-18. doi: 10.1016/j.psyneuen.2011.07.020. Epub 2011 Aug 20.
PubMed 21862226
Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. doi: 10.1038/nature03701.
PubMed 15931222
Lischke A, Gamer M, Berger C, Grossmann A, Hauenstein K, Heinrichs M, Herpertz SC, Domes G. Oxytocin increases amygdala reactivity to threatening scenes in females. Psychoneuroendocrinology. 2012 Sep;37(9):1431-8. doi: 10.1016/j.psyneuen.2012.01.011. Epub 2012 Feb 23.
PubMed 22365820
MacDonald E, Dadds MR, Brennan JL, Williams K, Levy F, Cauchi AJ. A review of safety, side-effects and subjective reactions to intranasal oxytocin in human research. Psychoneuroendocrinology. 2011 Sep;36(8):1114-26. doi: 10.1016/j.psyneuen.2011.02.015. Epub 2011 Mar 23.
PubMed 21429671
Miller JL, Lynn CH, Driscoll DC, Goldstone AP, Gold JA, Kimonis V, Dykens E, Butler MG, Shuster JJ, Driscoll DJ. Nutritional phases in Prader-Willi syndrome. Am J Med Genet A. 2011 May;155A(5):1040-9. doi: 10.1002/ajmg.a.33951. Epub 2011 Apr 4.
PubMed 21465655

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prader-Willi Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Intranasal Administrations of Oxytocin on Behavioural Troubles, Hyperphagia and Social Skills in Children With Prader-Willi Syndrome Aged From 3 to 12 Years.
ClinicalTrials.gov ID: NCT03114371
Acronym / sponsor ID: Oxyjeune / 15 7837 03
Conditions: Prader-Willi Syndrome
Keywords: Prader-Willi syndrome, Oxytocin, Behavioural troubles
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University Hospital, ToulouseUniversity, hospital or other
Study start: 28 Nov 2016 (actual)
Primary completion: Jan 2019 (actual)
Study completion: 11 Jan 2019 (actual)
First posted: 14 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Children will receive after randomization either placebo or oxytocin administration (daily intranasal) for a total duration of 12 consecutive weeks.

Arm	Type	Receives
Oxytocin	Experimental	Drug: OxytocinDaily intranasal administrations of oxytocin for 12 weeks, followed by an open-label period of 12 weeks of oxytocin. Oxytocin dose will be 8 International Unit for patients aged from 3 to 6 years and 16 International Unit for patients aged from 7 to 12 years.
Placebo	Placebo comparator	Drug: Placebo, Drug: OxytocinDaily intranasal administrations of placebo for 12 weeks, followed by an open-label period of 12 weeks of oxytocin. Oxytocin dose will be International Unit for patients aged from 3 to 6 years and 16 International Unit for patients aged from 7 to 12 years.

Who may qualify

Ages: 3 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

patient with a complete genetic diagnosis of Prader-Willi syndrome
patient treated by growth hormone for at least 1 year
patient naïve for oxytocin for at least 5 years

Key exclusion criteria (6 listed)

patient who do not accept intranasal administrations (major behavioural trouble)
patient with hepatic insufficiency : serum transaminases (SGOT, SGPT) higher than 3 times normal values for age
patient with renal insufficiency : serum creatinine higher than 3 times normal values for age
patient with an antecedent of abnormal electrocardiogram
patient with arterial hypertension or hypotension

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxytocinAlso: Intranasal administration of oxytocin (Week 1 to 12)The study drug is oxytocin in intra-nasal administration, Syntocinon®, reconditioned as a placebo-like spray. The dosage administered will be 8 International Unit, ie 1 spray (4 International Unit per spray) in each nostril per day for the first 12 weeks, in 3 and 6 years old patients. The dosage administered will be 16 International Unit or 2 sprays in each nostril per day for the first 12 weeks, in 3 to 6 years old patients.	Drug	Oxytocin
PlaceboAlso: Intranasal administration of placebo (Week 1 to 12)Placebo should be used as a spray, similar to that of the oxytocin. The dosage administered will be 1 spray in each nostril per day for the first 12 weeks in 3 to 6 years old patients. The dosage administered will be 2 sprays in each nostril per day for the first 12 weeks, in 7 to 12 years old patients.	Drug	Placebo
OxytocinAlso: Intranasal administration of oxytocin (Week 13 to 24)Each patient will receive oxytocin in open label (Syntocinon® not reconditioned) from week 13 to week 24 according to the same dosages.	Drug	Oxytocin, Placebo

Primary outcome

Evolution of behavioural troubles evaluated by the global score of Child Behavior Check List Questionnaire after 12 weeks of oxytocin/placebo treatment.
Time frame: Week 12
It's variation between inclusion and 12 weeks of total score total problems from the Child Behavior Check List Questionnaire.

8 secondary outcomes

Evaluation of hyperphagia after 12 weeks of oxytocin/placebo treatment.
Time frame: Week 12
Evaluation of social skills after 12 weeks of oxytocin/placebo treatment.
Time frame: Week 12
Evaluation of auto- and hetero-aggressive after 12 weeks of oxytocin/placebo treatment.
Time frame: Week 12
Evaluation of psychopathology after 12 weeks of oxytocin/placebo treatment.
Time frame: Week 12
Evaluation of global clinical status after 12 weeks of oxytocin/placebo treatment.
Time frame: Weeks 12
Evaluation of acyl and desacyl ghrelin plasma levels after 12 weeks of oxytocin/placebo treatment.
Time frame: Week 12
Evaluation of attentional abilities after 12 weeks of oxytocin/placebo treatment, for patients aged from 7 to 12 years at inclusion.
Time frame: Week 12
Evaluation of metabolic brain resting state after 12 weeks of oxytocin/placebo treatment, for patients aged from 7 to 12 years at inclusion.
Time frame: Week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
Background: PubMed 17236194Bittel DC, Kibiryeva N, Sell SM, Strong TV, Butler MG. Whole genome microarray analysis of gene expression in Prader-Willi syndrome. Am J Med Genet A. 2007 Mar 1;143A(5):430-42. doi: 10.1002/ajmg.a.31606.
Background: PubMed 15780853Constantino JN, Todd RD. Intergenerational transmission of subthreshold autistic traits in the general population. Biol Psychiatry. 2005 Mar 15;57(6):655-60. doi: 10.1016/j.biopsych.2004.12.014.
Background: PubMed 21858456Dykens EM, Lee E, Roof E. Prader-Willi syndrome and autism spectrum disorders: an evolving story. J Neurodev Disord. 2011 Sep;3(3):225-37. doi: 10.1007/s11689-011-9092-5. Epub 2011 Aug 20.
Background: PubMed 17636101Dykens EM, Maxwell MA, Pantino E, Kossler R, Roof E. Assessment of hyperphagia in Prader-Willi syndrome. Obesity (Silver Spring). 2007 Jul;15(7):1816-26. doi: 10.1038/oby.2007.216.
Background: PubMed 17598872Dykens E, Schwenk K, Maxwell M, Myatt B. The Sentence Completion and Three Wishes tasks: windows into the inner lives of people with intellectual disabilities. J Intellect Disabil Res. 2007 Aug;51(Pt 8):588-97. doi: 10.1111/j.1365-2788.2006.00937.x.
Background: PubMed 24980612Einfeld SL, Smith E, McGregor IS, Steinbeck K, Taffe J, Rice LJ, Horstead SK, Rogers N, Hodge MA, Guastella AJ. A double-blind randomized controlled trial of oxytocin nasal spray in Prader Willi syndrome. Am J Med Genet A. 2014 Sep;164A(9):2232-9. doi: 10.1002/ajmg.a.36653. Epub 2014 Jun 30.
Background: PubMed 11970796Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886.
Background: PubMed 22270375Goldstone AP, Holland AJ, Butler JV, Whittington JE. Appetite hormones and the transition to hyperphagia in children with Prader-Willi syndrome. Int J Obes (Lond). 2012 Dec;36(12):1564-70. doi: 10.1038/ijo.2011.274. Epub 2012 Jan 24.
Background: PubMed 19897177Guastella AJ, Einfeld SL, Gray KM, Rinehart NJ, Tonge BJ, Lambert TJ, Hickie IB. Intranasal oxytocin improves emotion recognition for youth with autism spectrum disorders. Biol Psychiatry. 2010 Apr 1;67(7):692-4. doi: 10.1016/j.biopsych.2009.09.020. Epub 2009 Nov 7.
Background: PubMed 25087908Guastella AJ, Gray KM, Rinehart NJ, Alvares GA, Tonge BJ, Hickie IB, Keating CM, Cacciotti-Saija C, Einfeld SL. The effects of a course of intranasal oxytocin on social behaviors in youth diagnosed with autism spectrum disorders: a randomized controlled trial. J Child Psychol Psychiatry. 2015 Apr;56(4):444-52. doi: 10.1111/jcpp.12305. Epub 2014 Aug 2.
Background: PubMed 21862226Hall SS, Lightbody AA, McCarthy BE, Parker KJ, Reiss AL. Effects of intranasal oxytocin on social anxiety in males with fragile X syndrome. Psychoneuroendocrinology. 2012 Apr;37(4):509-18. doi: 10.1016/j.psyneuen.2011.07.020. Epub 2011 Aug 20.
Background: PubMed 15931222Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. doi: 10.1038/nature03701.
Individual participant dataSharing planned: No

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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sophie ÇABAL-BERTHOUMIEU, Dr principal investigator

Centre de référence du syndrome de Prader-Willi, Hôpital des Enfants

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Oxytocin in people with Prader-Willi Syndrome, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evolution of behavioural troubles evaluated by the global score of Child Behavior Check List Questionnaire after 12 weeks of oxytocin/placebo treatment. (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03114371, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.