Clinical trial NCT06589505: Software as a Medical Device for the Treatment of Patients With PTSD
Official title: A Multicenter, Randomized, Double-blind, Parallel-group Comparative Study to Assess Efficacy and Safety of Software as a Medical Device in Patients With Post-Traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Post-Traumatic Stress Disorder, PTSD
Lead sponsor: Otsuka Medical Devices Co., Ltd. Japan
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2024-09-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PTSD according to the DSM-5
* Subjects who are within 1 to 20 years since index trauma

Exclusion Criteria:

* Subjects diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, autism spectrum disorder, or intellectual disability based on DSM-5.
* Subjects diagnosed with any mood disorder and anxiety disorder according to DSM-5 that is the primary focus of treatment in the last 6 months prior to screening, as per the clinical judgement of the investigator
* Subjects who have completed two or more full courses of trauma-focused therapy in the past

Primary outcomes:
measure: Clinician-Administered PTSD Scale for DSM-5
timeFrame: baseline and after intervention (up to 21 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Akita
country: Japan
facility: Heart Care Clinic Omachi
city: Fukuoka
country: Japan
facility: Aburayama Hospital
city: Fukuoka
country: Japan
facility: Ai Sakura Clinic
city: Fukuoka
country: Japan
facility: Hatakeyama Clinic
city: Fukuoka
country: Japan
facility: Hiro Mental Clinic
city: Fukuoka
country: Japan
facility: Hirota Clinic
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Fukuoka
country: Japan
facility: Medical corporation Shinseikai Kaku Mental Clinic
city: Fukuoka
country: Japan
facility: Mental Clinic Sakurazaka
city: Fukuoka
country: Japan
facility: Nishie Kokorono Clinic
city: Fukuoka
country: Japan
facility: Uematsu Mental Clinic
city: Gunma
country: Japan
facility: PTSD Care Matsumoto Mental Clinic
city: Hokkaido
country: Japan
facility: Goryokai Hospital
city: Hyōgo
country: Japan
facility: Sakamoto Misako Mental Clinic
city: Hyōgo
country: Japan
facility: Takahashi Psychiatric Clinic
city: Kanagawa
country: Japan
facility: Musashikosugi J Kokorono Clinic
city: Kumamoto
country: Japan
facility: Niki Hearty Hospital
city: Nagasaki
country: Japan
facility: Arata Clinic
city: Okayama
country: Japan
facility: Okayama Psychiatric Medical Center
city: Okinawa
country: Japan
facility: Barclay Imuro Mental Clinic
city: Osaka
country: Japan
facility: Medical Corporation Mikokorokai Shimizu Clinic
city: Saitama
country: Japan
facility: Sho Midori Hospital
city: Tochigi
country: Japan
facility: Ai Mental Clinic
city: Tokyo
country: Japan
facility: i Kokoro Clinic Nihonbashi
city: Tokyo
country: Japan
facility: Iidabashi Mental Clinic
city: Tokyo
country: Japan
facility: Ikebukuro Olive Mental Clinic
city: Tokyo
country: Japan
facility: Kitaikebukuro Kokoro No Clinic
city: Tokyo
country: Japan
facility: Maynds Tower Mental Clinic
city: Tokyo
country: Japan
facility: Monzennakacho Mental Clinic
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: Sakurazaka Clinic SophyAnce
city: Tokyo
country: Japan
facility: Sangenjaya Nakamura Mental Clinic
city: Tokyo
country: Japan
facility: Wakamatsucho Kokoro to Hifu Clinic
Study officials:
References: