UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028461 |
|---|---|
| Receipt number | 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 18:09:47 |
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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
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
sogoutiger@nifty.com
Sponsor or person
Institute
SOGO PTSD INSTITUTE
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032432
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