UMIN-CTR Clinical Trial

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