UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017529 |
|---|---|
| Receipt number | R000020315 |
| Scientific Title | The study for adjunctive lithium for extended effect on antidepressant action of ketamine and its neural correlates. |
| Date of disclosure of the study information | 2015/05/12 |
| Last modified on | 2020/10/28 18:19:29 |
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Basic information
Public title
The study for adjunctive lithium for extended effect on antidepressant action of ketamine and its neural correlates.
Acronym
Adjunctive treatment of lithium for extended action of ketamine. (ATLEK study)
Scientific Title
The study for adjunctive lithium for extended effect on antidepressant action of ketamine and its neural correlates.
Scientific Title:Acronym
Adjunctive treatment of lithium for extended action of ketamine. (ATLEK study)
Region
| Japan |
Condition
Condition
Treatment-resistant monopolar/bipolar depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the efficacy and safety of combination of ketamine plus lithium in patients with treatment resistant (monopolar/bipolar) depression (TRD) using a randomized, double blind, placebo-controlled design.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Montgomery Asberg Depression Rating Scale
Key secondary outcomes
Hamilton Depressive Scare
Serum BDNF, Plasma HVA, MHPG
Functional connectivity between dorsal nexus and precuneus using rfMRI.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Discontinuation of previous medication.
Taking Lithium carbonate (400mg-1000mg, serum level >=0.6mEq) .
Repetitive (twice a week, 4 times total) administration of ketamine (0.5mg/kg/40min).
Interventions/Control_2
Discontinuation of previous medication.
Placebo pills at night for duration of the study.
Repetitive (twice a week, 4 times total) administration of ketamine (0.5mg/kg/40min).
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Participants must fulfill ICD-10 criteria for F32 Major Depression, F33 Recurrent major depression, F31 Bipolar disorder
2.Participants who diagnosed F32 Major Depression, F33 Recurrent major depression have not responded to two or more adequate trials of an antidepressant (>=imipramine equivalent 150mg) for at least 4-6 weeks. Participants who diagnosed F31 Bipolar disorder have not responded to adequate trials of mood stabilizer or olanzapine or quetiapine.
3.Current Major Depressive Episode of at least moderate severity, defined as a HAM-D 17 score >=18.
4.Each participant must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document.
Key exclusion criteria
1.Patients with any clinically significant psychiatric disorder other than ICD-10 criteria for F32, F33, F31.
2.Patients with Lifetime history of mood-incongruent psychotic features based on DSM-IV-TR.
3.Patients judged clinically to be at serious and imminent suicidal or homicidal risk.
4.Imminent risk of other harm.
5.Patients with any organic brain disease.
6.Patients with unstable medical illness.
7.Patients treated with lithium within two weeks of consent.
8.Patients who are intolerant to Ketamine or Lithium because of reasons below; thyroid dysfunction, parathyroid dysfunction, renal dysfunction, atrio-ventricular block, epilepsy, uncontrolled hypertension, adverse events in using ketamine or lithium ever before.
9.Women who are pregnant or who wish to become pregnant during the research.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Horikawa |
Organization
Kurume University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
8300011
Address
67,Asahi-machi,Kurume,Fukuoka
TEL
0942-31-7564
horikawa_naoki@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Horikawa |
Organization
Kurume University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
8300011
Address
67,Asahi-machi,Kurume,Fukuoka
TEL
0942-31-7564
Homepage URL
horikawa_naoki@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
None
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
The Ethical Committee of Kurume University
Address
Asahimachi67, Kurume
Tel
0942-31-7917
sangaku@kurume-u.ac.jp
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
久留米大学病院（福岡県） Kurume University Hospital(Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2020 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020315
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