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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023581
Enrollment
90
Registered
2018-12-31
Start date
2015-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treating Major Depression

Interventions

DCS PLACEBO

Sponsors

Ministry of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Asia(except Japan)

Contacts

Public ContactTung Ping Su

Taipei Veterans General Hospital Psychiatry

tomsu0402@gmail.com+886-2-28757778

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026