UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007877 |
|---|---|
| Receipt number | R000009279 |
| Scientific Title | Adjunctive acetaminophen therapy for Major Depression |
| Date of disclosure of the study information | 2012/05/02 |
| Last modified on | 2014/04/29 09:08:19 |
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Basic information
Public title
Adjunctive acetaminophen therapy for Major Depression
Acronym
Adjunctive acetaminophen therapy for Major Depression
Scientific Title
Adjunctive acetaminophen therapy for Major Depression
Scientific Title:Acronym
Adjunctive acetaminophen therapy for Major Depression
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of adjunctive acetaminophen in the treatment of major depressive disorder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Montgomery-Asberg Depression Scale (MADRS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adjunctive acetaminophen therapy for Major Depression
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1,Patients with major depressive disorder (DSM-4)
2,20 to 80 years of age, were recruited. 3,They were required to show no remarkable change of symptom more than 4weeks under the same medications. Patients who showed less than 20% improvements in the Montgomery-Asberg Depression Rating Scale (MADRS) from screening to baseline
were included to the study.
Key exclusion criteria
1,Having a serious physical disease..
2,The presence of previous history of side effects or allergy about Acetaminophen
3,Past history of asthma
4,Past history of heart disease
5,Past history of upper gastrointestinal disease such as gastritis
6,Blood disease
7,Bleeding tendency
8,Liver disease
9,Renal disease
10,Heavy drinker
11,Malnutrition
12,Manic-depressive illness
13,Epilepsy
14,More than 5 points of suicidal thoughts MADRS
15,The presence of psychotic symptom
16,There is no therapeutic response to antidepressants for more than three drugs in the past
17,Pregnant or Breast-feeding
18,Those taking anticoagulants such as Warfarin, Those taking thiazide diuretics, quinolone antibiotics, lithium, carbamazepine, phenobarbital, phenytoin, primidone
19,Those already taking the medicines that contain acetaminophen
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jinichi Hirano |
Organization
School of Medicine, Keio University
Division name
Department of Neuropsychiatry,
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Keio University
Division name
Department of Neuropsychiatry,
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Oizumi Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 05 | Month | 02 | 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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | 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
| 2012 | Year | 05 | Month | 02 | Day |
Last modified on
| 2014 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009279
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
