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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028461
Receipt No. R000032432
Scientific Title New drug treatment and mechanism of action of the central anticholinergic drug trihexylphenidyl in reducung posttraumatic nightmares and Fiashbacks in patients with posttraumtic stress disoder,and the occurrence hyposthesis of nightmares and flashbacks.
Date of disclosure of the study information 2017/07/31
Last modified on 2017/07/31

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Basic information
Public title New drug treatment and mechanism of action of the central anticholinergic drug trihexylphenidyl in reducung posttraumatic nightmares and Fiashbacks in patients with posttraumtic stress disoder,and the occurrence hyposthesis of nightmares and flashbacks.
Acronym the new drug treatment:cehtral anticgolinergic drug Truhexylphenidyl in posttraumatic nightmares and the drug effect mechanism.
Scientific Title New drug treatment and mechanism of action of the central anticholinergic drug trihexylphenidyl in reducung posttraumatic nightmares and Fiashbacks in patients with posttraumtic stress disoder,and the occurrence hyposthesis of nightmares and flashbacks.
Scientific Title:Acronym the new drug treatment:cehtral anticgolinergic drug Truhexylphenidyl in posttraumatic nightmares and the drug effect mechanism.
Region
Japan

Condition
Condition posttraumatic stress disorder.
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Mechanism of occurrence(hypothesis)of poattraumatic nightmares and new drug treatment:central anticholinergic agent:Trihexylphenidyl showed aimost 100% more efficacy against posttraumatic nightmares, and on the effect mechanism of this drug.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Central anticholinergic drug:Trihexylphenidyl (an existing drug was used from 65 years ago)administered to refractory PTSD-patients with posttraumaic nightmares. Respond to symptom to refractory PTSD who came in 2009~2017,Trihexylphenidyl 2mg/1T~3T was administered.It was evaluated by CAPS(Clinical Administered PTSD Scale) and IES-R( the Impact of Event Scale-Revised). Clinical evalluation is suprising to say that Complete Remission:70.3%+Partial Remission:29.7%=almost 100%. Moreover, this medicine is fast-acting, certainty, drug mechanism clear.
Key secondary outcomes I found the following onset hypothesis from this research. The hypothesis of flashbacks has a deep relationship with the brain ACh basal ganglia(Ch1,Ch2,Ch4) and amygdala,hippocampus. The hypothesis of posttraumatic nightmares has a deep relationship with hypothesis of flashbacks and Ch5,Ch6 of the brain stem which is said to occur regular REM.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Using the cehtral anticholinergic agent Trihexylphenidyl for posttraumatic nightmares and observe therapeutic effect.Trihexylphenidyl2mg1T~2T is administered before bedtime.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria Originally PTSD may nave refractory elements, but at the time of first visit our clinic, patients with intractable PTSD who already received various treatments at various medical institutions were targeted.
Key exclusion criteria Men and women aged under 20 and over 40 years old, pregnant women, lactating women were excluded.
Target sample size 29

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsumasa Sogo
Organization Medical Corporation Sogo-kai Sogo Clinic
Division name SOGO-PTSD INSTITUTE
Zip code
Address 7-20 1-choume matoba-cho minami-ku hiroshima-city.
TEL 082-261-0280
Email sogoutiger@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Katsumasa Sogo
Organization Medical Corporation Sogo-kai Sogo-Clinic
Division name sogo ptsd institute
Zip code
Address 1 choume matoba cho minami ku hiroshima city
TEL 082-261-0280
Homepage URL http://www.sogo-clinic.jp
Email sogoutiger@nifty.com

Sponsor
Institute SOGO PTSD INSTITUTE
Institute
Department

Funding Source
Organization Medical Corporation Sogo Kai Sogou Clinic
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 31 Day
Last modified on
2017 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032432

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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