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Intranasal oxytocin versus placebo in the treatment of adults with autism spectrum disorders: a randomized controlled trial.

Anagnostou E, Soorya L, Chaplin W, Bartz J, Halpern D, Wasserman S, Wang AT, Pepa L, Tanel N, Kushki A, Hollander E - Mol Autism (2012)

Bottom Line: The primary aim of this study was to examine the safety/therapeutic effects of intranasal oxytocin versus placebo in adults with ASD, with respect to the two core symptom domains of social cognition/functioning and repetitive behaviors.Oxytocin was well tolerated and no serious adverse effects were reported.NCT00490802.

View Article: PubMed Central - HTML - PubMed

Affiliation: Mount Sinai School of Medicine, One Gustave L, Levy Place, New York, NY 10029-6574, USA. eanagnostou@hollandbloorview.ca.

ABSTRACT

Background: There are no effective medications for the treatment of social cognition/function deficits in autism spectrum disorder (ASD), and adult intervention literature in this area is sparse. Emerging data from animal models and genetic association studies as well as early, single-dose intervention studies suggest that the oxytocin system may be a potential therapeutic target for social cognition/function deficits in ASD. The primary aim of this study was to examine the safety/therapeutic effects of intranasal oxytocin versus placebo in adults with ASD, with respect to the two core symptom domains of social cognition/functioning and repetitive behaviors.

Methods: This was a pilot, randomized, double-blind, placebo-controlled, parallel design trial of intranasal oxytocin versus placebo in 19 adults with ASD (16 males; 33.20 ± 13.29 years). Subjects were randomized to 24 IU intranasal oxytocin or placebo in the morning and afternoon for 6 weeks. Measures of social function/cognition (the Diagnostic Analysis of Nonverbal Accuracy) and repetitive behaviors (Repetitive Behavior Scale Revised) were administered. Secondary measures included the Social Responsiveness Scale, Reading-the-Mind-in-the-Eyes Test and the Yale Brown Obsessive Compulsive Scale - compulsion subscale and quality of life (World Health Organization Quality of Life Questionnaire - emotional/social subscales). Full-information maximum-likelihood parameter estimates were obtained and tested using mixed-effects regression analyses.

Results: Although no significant changes were detected in the primary outcome measures after correcting for baseline differences, results suggested improvements after 6 weeks in measures of social cognition (Reading-the-Mind-in-the-Eyes Test, p = 0.002, d = 1.2), and quality of life (World Health Organization Quality of Life Questionnaire - emotion, p = 0.031, d = 0.84), both secondary measures. Oxytocin was well tolerated and no serious adverse effects were reported.

Conclusions: This pilot study suggests that there is therapeutic potential to daily administration of intranasal oxytocin in adults with ASD and that larger and longer studies are warranted.

Trial registration: NCT00490802.

No MeSH data available.


Related in: MedlinePlus

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Figure 1: Consort flow diagram.

Mentions: Nineteen adults (16 males and three females, mean age 33.2 ± 13.3 years) (Figure1) with a diagnosis of high-functioning autism or Asperger’s disorder (Autism Diagnostic Observation Schedule –social + communication, 8.17 (3.24); Autism Diagnostic Interview – social, 18.3 (6.3); Autism Diagnostic Interview – communication, 14.2 (6.5); Autism Diagnostic Interview – repetitive, 6 (4.1)) were recruited into a 6-week randomized placebo controlled trial. Ten participants received oxytocin and nine received placebo. There were no significant differences in age (mean (standard deviation): oxytocin, 33.8 (12.7); placebo, 32.9 (14.4); t = 0.14, df = 17, P = 0.88) or full-scale IQ (mean (standard deviation): oxytocin, 99 (22); placebo, 118 (19); t = 1.94216, df = 16, P = 0.07) (Table1).


Intranasal oxytocin versus placebo in the treatment of adults with autism spectrum disorders: a randomized controlled trial.

Anagnostou E, Soorya L, Chaplin W, Bartz J, Halpern D, Wasserman S, Wang AT, Pepa L, Tanel N, Kushki A, Hollander E - Mol Autism (2012)

Consort flow diagram.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3539865&req=5

Figure 1: Consort flow diagram.
Mentions: Nineteen adults (16 males and three females, mean age 33.2 ± 13.3 years) (Figure1) with a diagnosis of high-functioning autism or Asperger’s disorder (Autism Diagnostic Observation Schedule –social + communication, 8.17 (3.24); Autism Diagnostic Interview – social, 18.3 (6.3); Autism Diagnostic Interview – communication, 14.2 (6.5); Autism Diagnostic Interview – repetitive, 6 (4.1)) were recruited into a 6-week randomized placebo controlled trial. Ten participants received oxytocin and nine received placebo. There were no significant differences in age (mean (standard deviation): oxytocin, 33.8 (12.7); placebo, 32.9 (14.4); t = 0.14, df = 17, P = 0.88) or full-scale IQ (mean (standard deviation): oxytocin, 99 (22); placebo, 118 (19); t = 1.94216, df = 16, P = 0.07) (Table1).

Bottom Line: The primary aim of this study was to examine the safety/therapeutic effects of intranasal oxytocin versus placebo in adults with ASD, with respect to the two core symptom domains of social cognition/functioning and repetitive behaviors.Oxytocin was well tolerated and no serious adverse effects were reported.NCT00490802.

View Article: PubMed Central - HTML - PubMed

Affiliation: Mount Sinai School of Medicine, One Gustave L, Levy Place, New York, NY 10029-6574, USA. eanagnostou@hollandbloorview.ca.

ABSTRACT

Background: There are no effective medications for the treatment of social cognition/function deficits in autism spectrum disorder (ASD), and adult intervention literature in this area is sparse. Emerging data from animal models and genetic association studies as well as early, single-dose intervention studies suggest that the oxytocin system may be a potential therapeutic target for social cognition/function deficits in ASD. The primary aim of this study was to examine the safety/therapeutic effects of intranasal oxytocin versus placebo in adults with ASD, with respect to the two core symptom domains of social cognition/functioning and repetitive behaviors.

Methods: This was a pilot, randomized, double-blind, placebo-controlled, parallel design trial of intranasal oxytocin versus placebo in 19 adults with ASD (16 males; 33.20 ± 13.29 years). Subjects were randomized to 24 IU intranasal oxytocin or placebo in the morning and afternoon for 6 weeks. Measures of social function/cognition (the Diagnostic Analysis of Nonverbal Accuracy) and repetitive behaviors (Repetitive Behavior Scale Revised) were administered. Secondary measures included the Social Responsiveness Scale, Reading-the-Mind-in-the-Eyes Test and the Yale Brown Obsessive Compulsive Scale - compulsion subscale and quality of life (World Health Organization Quality of Life Questionnaire - emotional/social subscales). Full-information maximum-likelihood parameter estimates were obtained and tested using mixed-effects regression analyses.

Results: Although no significant changes were detected in the primary outcome measures after correcting for baseline differences, results suggested improvements after 6 weeks in measures of social cognition (Reading-the-Mind-in-the-Eyes Test, p = 0.002, d = 1.2), and quality of life (World Health Organization Quality of Life Questionnaire - emotion, p = 0.031, d = 0.84), both secondary measures. Oxytocin was well tolerated and no serious adverse effects were reported.

Conclusions: This pilot study suggests that there is therapeutic potential to daily administration of intranasal oxytocin in adults with ASD and that larger and longer studies are warranted.

Trial registration: NCT00490802.

No MeSH data available.


Related in: MedlinePlus