UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017529
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email horikawa_naoki@kurume-u.ac.jp

Sponsor
Institute Kurume University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020315

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.