An early phase II trial for efficacy and safety of TTA-121 on autism spectrum disorder
- Conditions
- Autism spectrum disorder
- Registration Number
- JPRN-UMIN000031412
- Lead Sponsor
- Hamamatsu University School of Medicine, Department of Psychiatry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 144
Not provided
(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 spectrum 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) Pariticipation 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method