UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046148 |
|---|---|
| Receipt number | R000052633 |
| Scientific Title | Low-dose ketamine infusion among adolescents with treatment-resistant depression: a randomized, double-blind placebo-control study. |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2022/01/10 12:29:08 |
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Basic information
Public title
Low-dose ketamine infusion among adolescents with treatment-resistant depression: a randomized, double-blind placebo-control study.
Acronym
Low-dose ketamine infusion among adolescents with treatment-resistant depression.
Scientific Title
Low-dose ketamine infusion among adolescents with treatment-resistant depression: a randomized, double-blind placebo-control study.
Scientific Title:Acronym
Low-dose ketamine infusion among adolescents with treatment-resistant depression.
Region
| Asia(except Japan) |
Condition
Condition
treatment-resistant depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess the rapid antidepressant and antisuicidal effects of low-dose ketamine infusion in adolescents with treatment-resistant depression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Changes in depressive symptoms measured by Montgomery-Asberg Depression Rating Scale (MADRS) in adolescents with treatment-resistant depression.
2. Changes in depressive symptoms measured by Hamilton Rating Scale for Depression (HAMD) in adolescents with treatment-resistant depression.
3. Changes in depressive symptoms measured by Children's Depression Rating Scale-Revised (CDRS-R) in adolescents with treatment-resistant depression.
[Time Frame: clinical visit or telephone visit evaluation times are Day 1, 2, 3, 4, 5, 6, 7, 14, and 28]
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Arm1: Two 0.5mg/kg ketamine infusions
Interventions/Control_2
Arm2: First 0.045mg/kg midazolam infusion and Second 0.5mg/kg ketamine infusion
Interventions/Control_3
Arm3: Two 0.045mg/kg midazolam infusions
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
| 13 | years-old | <= |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Major depressive episode including unipolar and bipolar depression, according to DSM-5 criteria and MINI-adolescent version (Mini-International Neuropsychiatric Interview; MINI) diagnostic interview.
(2)Age >= 13y/o < 20 y/o
(3)Body weigh >= 30 kg.
(4)Treatment-resistant depression, which is defined as poor or unsatisfactory response to at least two different antidepressants administered at an adequate dosage and for an adequate treatment duration
(5)Still prominent depressive symptoms with at least 4-week treatment of medication treatment or psychotherapy
(6)Voluntary patients and their parents or guardians with signed informed consent proved by institutional review board (IRB)
Key exclusion criteria
(1)Major medical conditions (e.g., head injury, epilepsy, severe renal diseases and cancer).
(2)Other axis I psychiatric disorders such as schizophrenia, delusional disorder, organic brain syndrome, and dementia.
(3)Pregnancy.
(4)Substance abuse in previous 6 months such as cocaine, marijuana, opium, ketamine, PCP (phencyclidine).
(5)Current use of NMDA receptor antagonist (Amantadine, Rimantadine, Lamotrigine, Memantine, Dextromethorphan)
(6)Alcohol abuse / dependence within 6 months.
(7)Attempt suicide in hospital.
(8)Allergy to ketamine.
(9)Abnormal liver function in recent 3 months.
(10) Abnormal ECG (i.e.:arrhythmia).
(11) Fever or infection in recent 5 days.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Mu-Hong |
| Middle name | |
| Last name | Chen |
Organization
Taipei Veterans General Hospital,Taiwan
Division name
Department of Psychiatry
Zip code
112
Address
No. 201, Shih-Pai Road, Sec. 2, 11217, Taipei, Taiwan.
TEL
+886228757027
kremer7119@gmail.com
Public contact
Name of contact person
| 1st name | Mu-Hong |
| Middle name | |
| Last name | Chen |
Organization
Taipei Veterans General Hospital,Taiwan
Division name
Department of Psychiatry
Zip code
112
Address
No. 201, Shih-Pai Road, Sec. 2, 11217, Taipei, Taiwan.
TEL
+886228757027
Homepage URL
kremer7119@gmail.com
Sponsor or person
Institute
Ministry of Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Science and Technology
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board Taipei Veterans General Hospital,Taiwan
Address
No. 201, Shih-Pai Road, Sec. 2, 11217, Taipei, Taiwan.
Tel
+886228757384
irbopinion@vghtpe.gov.tw
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
| 2021 | Year | 12 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 23 | Day |
Last modified on
| 2022 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052633
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