Ketamine in treatment resistant major depression (TRD)

Phase 1

• Conditions: Therapy resistant depression; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-023414-31-DE
• Lead Sponsor: Medizinische Fakultät. Otto von Guericke Universität

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Last Update Posted: 9 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified