Treating Major Depression
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Taipei Veterans General Hospital Psychiatry