UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023581 |
|---|---|
| Receipt number | 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 | 2021/11/18 12:03:59 |
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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 | 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
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
tomsu0402@gmail.com
Sponsor or person
Institute
Ministry of Science and Technology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027142
