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 |
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
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
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
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
Asia(except Japan) |
Treating Major Depression
Psychiatry |
Others
NO
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.
Efficacy
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.
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.
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Placebo
No need to know
2
Treatment
Medicine |
DCS
PLACEBO
20 | years-old | <= |
65 | years-old | > |
Male and Female
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)
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.
90
1st name | Tung Ping |
Middle name | |
Last name | Su |
Taipei Veterans General Hospital
Psychiatry
112
No.201, Sec.2, Shih-Pai Road, Beitou district
+886-2-28757778
ju.orangesea@gmail.com
1st name | Tung Ping |
Middle name | |
Last name | Su |
Taipei Veterans General Hospital
Psychiatry
112
No.201, Sec.2, Shih-Pai Road, Beitou district
+886-2-28757778
tomsu0402@gmail.com
Ministry of Science and Technology
Ministry of Science and Technology
Outside Japan
Taipei Veterans General Hospital, Taiwan
No.201, Sec.2, Shih-Pai Rd, Beitou district, Taipei, Taiwan
886-2-28757384
slchang@vghtpe.gov.tw
NO
2018 | Year | 12 | Month | 31 | Day |
Unpublished
Completed
2015 | Year | 01 | Month | 01 | Day |
2014 | Year | 07 | Month | 14 | Day |
2015 | Year | 08 | Month | 01 | Day |
2017 | Year | 12 | Month | 22 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 05 | Month | 30 | Day |
2018 | Year | 08 | Month | 07 | Day |
2016 | Year | 08 | Month | 10 | Day |
2021 | Year | 11 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027142