UMIN-CTR Clinical Trial

Basic information
Public title	Maintaining the antidepressant effect with D-cycloserine, a NMDA receptor partial agonist, following acute ketamine infusion for treatment resistant depression: A randomized double-blind placebo-controlled study
Acronym	Maintaining the antidepressant effect with D-cycloserine, a NMDA receptor partial agonist, following acute ketamine infusion for treatment resistant depression: A randomized double-blind placebo-controlled study
Scientific Title	Maintaining the antidepressant effect with D-cycloserine, a NMDA receptor partial agonist, following acute ketamine infusion for treatment resistant depression: A randomized double-blind placebo-controlled study
Scientific Title:Acronym	Maintaining the antidepressant effect with D-cycloserine, a NMDA receptor partial agonist, following acute ketamine infusion for treatment resistant depression: A randomized double-blind placebo-controlled study
Region	Asia(except Japan)

Condition
Condition	Treating Major Depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1) To assess the maintaining antidepressant effect of D-cycloserine (DCS) and its ability to prevent relapse of depression (i.e., increase of MADRS depression score vs. baseline >= 30%). 2) To evaluate the clinical efficacy of two repeated ketamine infusions on TRD patients within one week. 3) To search for variant of BDNF polymorphism, BDNF & glycine levels and cytokines to be biomarker for predicting clinical response. 4) To find the correlation of changes of brain imaging with ketamine or DCS with antidepressant effect, thereby explore the neurocircuitry related to treatment with glutamate-related agents.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To assess the maintaining antidepressant effect of D-cycloserine (DCS) on responders of ketamine infusion by comparing the relapse rates of treatment (D-cycloserine) and placebo group in Stage II. Relapse is defined as two consecutive nonresponses (MADRS depression score is 30% higher than Baseline of Stage II).The difference between two relapse rates larger than 30% will be regarded as efficacy.
Key secondary outcomes	1) To evaluate the clinical efficacy of two repeated ketamine infusions on TRD patients within one week. 2) To search for variant of BDNF polymorphism, BDNF & glycine levels and cytokines to be biomarker for predicting clinical response. 3) To find the correlation of changes of brain imaging with ketamine or DCS with antidepressant effect, thereby explore the neurocircuitry related to treatment with glutamate-related agents. 4) To use EEG biomarkers, i.e., normalization of left - right ratio of brain waves following ketamine infusion, to predict better response to DCS treatment.

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	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	DCS
Interventions/Control_2	PLACEBO
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Major depression including unipolar and bipolar depression. 2.Age>=20y/o<65 y/o 3.Treatment resistant depression was defined as the depressed subjects failed to respond to at least two antidepressants with their optimal dose and over four week treatment in previous medication history. 4.Patient on stabilized background medications. 5.moderate to severe depressive symptoms (MADRS>=25, HAMD-17>=18)
Key exclusion criteria	1.Major medical conditions. 2.Other axis I psychiatric disorders such as schizophrenia, delusional disorder, organic brain syndrome, and dementia. 3.Pregnancy or lactation 4.Hypersensitive to D-cycloserine and Ketamine 5.Substance abuse in previous 6 months such as cocaine, marijuana, opium, ketamine, PCP (phencyclidine). 6.Current use of NMDA receptor antagonist (Amantadine, Rimantadine, Lamotrigine, Memantine, Dextromethorphan). 7.Alcohol abuse / dependence within 6 months. 8.Attempt suicide in hospital. 9.Risk for current homicidal tendency.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Tung Ping Middle name Last name Su
Organization	Taipei Veterans General Hospital
Division name	Psychiatry
Zip code	112
Address	No.201, Sec.2, Shih-Pai Road, Beitou district
TEL	+886-2-28757778
Email	ju.orangesea@gmail.com

Public contact
Name of contact person	1st name Tung Ping Middle name Last name Su
Organization	Taipei Veterans General Hospital
Division name	Psychiatry
Zip code	112
Address	No.201, Sec.2, Shih-Pai Road, Beitou district
TEL	+886-2-28757778
Homepage URL
Email	tomsu0402@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	Taipei Veterans General Hospital, Taiwan
Address	No.201, Sec.2, Shih-Pai Rd, Beitou district, Taipei, Taiwan
Tel	886-2-28757384
Email	slchang@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	2018 Year 12 Month 31 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	Completed
Date of protocol fixation	2015 Year 01 Month 01 Day
Date of IRB	2014 Year 07 Month 14 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2017 Year 12 Month 22 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 05 Month 30 Day
Date analysis concluded	2018 Year 08 Month 07 Day

Other
Other related information

Management information
Registered date	2016 Year 08 Month 10 Day
Last modified on	2021 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027142