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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023581
Receipt No. R000027142
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
Date of disclosure of the study information 2018/12/31
Last modified on 2016/08/10

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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
Middle name
Last name Tung-Ping Su
Organization Taipei Veterans General Hospital
Division name Psychiatry
Zip code
Address No.201, Sec.2, Shih-Pai Road, Beitou district
TEL +886-2-28757778
Email tomsu0402@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tung-Ping Su
Organization Taipei Veterans General Hospital
Division name Psychiatry
Zip code
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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

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


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

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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