A Trial of TTA-121 on Autism Spectrum Disorder

Hamamatsu University

Status and phase: Unknown; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Drug: TTA-121

Study type: Interventional

Funder types: Other

Identifiers

NCT03466671

UMIN000031412

Details and patient eligibility

About

To test efficacy and safety of a novel nasal spray of oxytocin on social deifies in autism spectrum disorder, and To compare effect sizes of different doses

Enrollment: 144 estimated patients

Sex: Male

Ages: 18 to 54 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of autism spectrum disorder based on Diagnostic and Statistical Manual of Mental Disorders-V with score exceeding the cut-off value of 10 for qualitative abnormalities in social reciprocity on Autism Diagnostic Interview Revised (ADIR)
2. Full scale Intelligent quotient above 80 as measured using the Wechsler Adult Intelligent Scale-III
3. Written informed consent for participating the trial

Exclusion criteria

1. Diagnosis of bipolar disorder or schizophrenia spectrum disorder
2. Primary diagnosis of depressive disorders, obsessive-compulsive and related disorders, anxiety disorders, trauma- and stressor-related disorders, dissociative disorders, somatic symptom and related disorders, or neurodevelopmental disorders other than autism spectr um disorder
3. Instability in symptoms of comorbid mental disorders such as depressive disorders or anxiety disorders
4. History of changes in medication or doses of psychotropics within one month before registration
5. Current treatment with more than one psychotropics
6. History of hyper-sensitivity to oxytocin
7. History of seizures or traumatic brain injury with loss of consciousness for longer than 5 minutes
8. History of alcohol-related disorders, substance abuse, or addiction
9. Family history of male breast cancer
10. Subject who has severe complications
11. Known hypersensitivity to some drugs and foods
12. Subject who is not able to consent contraception during study period
13. Participation in another registration clinical trial and administration of investigational drug during 120 days before informed consent
14. Other Subjects whom a lead investigator or the patient's primary physician deems are not appropriate for this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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144 participants in 8 patient groups

Low dose once per day and placebo

Other group

Description:

Four weeks administrations of TTA-121 3U once per day in morning and placebo once per day in evening. After four weeks washout, four weeks administrations of placebo twice per day in morning and evening.

Treatment:

Drug: TTA-121

Low dose twice per day and placebo

Other group

Description:

Four weeks administrations of TTA-121 3U twice per day in morning and evening. After four weeks washout, four weeks administrations of placebo twice per day in morning and evening.

Treatment:

Drug: TTA-121

High dose once per day and placebo

Other group

Description:

Four weeks administrations of TTA-121 10U once per day in morning and placebo once per day in evening. After four weeks washout, four weeks administrations of placebo twice per day in morning and evening.

Treatment:

Drug: TTA-121

High dose twice per day and placebo

Other group

Description:

Four weeks administrations of TTA-121 10U twice per day in morning and evening. After four weeks washout, four weeks administrations of placebo twice per day in morning and evening.

Treatment:

Drug: TTA-121

Placebo and low dose once per day

Other group

Description:

Four weeks administrations of placebo twice per day in morning and evening. After four weeks washout, four weeks administrations of TTA-121 3U once per day in morning and placebo once per day in evening.

Treatment:

Drug: TTA-121

Placebo and low dose twice per day

Other group

Description:

Four weeks administrations of placebo twice per day in morning and evening. After four weeks washout, four weeks administrations of TTA-121 3U twice per day in morning and evening.

Treatment:

Drug: TTA-121

Placebo and high dose once per day

Other group

Description:

Four weeks administrations of placebo twice per day in morning and evening. After four weeks washout, four weeks administrations of TTA-121 10U once per day in morning and placebo once per day in evening.

Treatment:

Drug: TTA-121

Placebo and high dose twice per day

Other group

Description:

Four weeks administrations of placebo twice per day in morning and evening. After four weeks washout, four weeks administrations of TTA-121 10U twice per day in morning and evening.

Treatment:

Drug: TTA-121