EUCTR2010-023414-31-DEActive, not recruitingPhase 1
Ketamine in treatment resistant major depression (TRD) - KETREST
Medizinische Fakultät. Otto von Guericke Universität0 sitesStarted: March 8, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •patients (age 18-55) with recurrent major depressive disorder for at least 5 years on a stable regimen of psychotropic medications for > 6 weeks before study entry, Hamilton Depression Rating Scale (HAMD, 21 item) scores = 18, with failed responses to at least 2 previous adequate (guideline conform) treatment attempts during the recent episode.
- •Treatment resistance is defined by
- •1) unsuccessful adequate trials ( >6 weeks at maximum recommended or tolerated dose) of primary antidepressant drugs from at least three different classes;
- •2) unsuccessful adequate trials ( > 4 weeks) of augmentation/combination strategies using a primary antidepressant with at least two other different agents;
- •Treatment resistance will be quantified after inclusion using the Antidepressant Treatment History Form (ATHF).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Exclusion criteria include pregnancy, history of psychotic symptoms, increased intraorbital pressures, known neurological comorbidities, cardiac exclusion criteria include arterial hypertension, arythmia, congenital heart failures, hearth insufficience (NYHA II or higher) and coronary heart disease. Further exclusion criteria consist of any history of substance abuse or psychiatric comorbidities requiring additional treatment, known adverse responses during previous surgical procedures requiring anaesthesia such as delirium. Specific MR exclusion criteria comprise metal implants, claustrophobia, tattoos and tinnitus.
Investigators
Similar Trials
Completed
Phase 2
Ketamine in treatment resistant major depression (TRD) -A placebo controlled, double blind, randomized trial of efficacy, safety and response prediction by resting state fMRIwith healthy volunteersF33Recurrent depressive disorderDRKS00003527Otto-von-Guericke University MagdeburgMedical Faculty91
Completed
Not Applicable
Ketamine in treatment-resistant major depressioTreatment-resistant major depressionMental and Behavioural DisordersDepressionISRCTN28417759niversity of Kuopio (Finland)100
Completed
Not Applicable
Role Of Ketamine in Treatment-Resistant Major Depressive Disorder And Its Effect on SuicidalityTreatment Resistant DepressionNCT04101474Assiut University36
Active, not recruiting
Phase 1
A study to look at Ketamine as an additional treatment for people with depressioMajor DepressionEUCTR2019-003109-92-IETrinity College Dublin104
Active, not recruiting
Phase 1
Ketamine as an adjunctive therapy for Major Depression - a randomised controlled pilot trial: The KARMA-Dep TrialDepressionEUCTR2016-004764-18-IESt Patrick’s Mental Health Services25