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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046148
Receipt No. 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

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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
Email 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
Email kremer7119@gmail.com

Sponsor
Institute Ministry of Science and Technology
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052633

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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