NCT01868802.

Study name	Ketamine for treatment‐resistant depression: a multicentric clinical trial in Mexican population
Methods	A randomised multicentric parallel arms study involving the use of ketamine for treatment‐resistant depression will be held at three national health provider clinics in the Mexican population Allocation: randomised Endpoint classification: safety/efficacy study Intervention model: parallel assignment Masking: double‐blind (participant, caregiver, investigator) Primary purpose: treatment
Participants	Inclusion criteria Age: 18‐65 years old Mayor Depressive Disorder Diagnosis based on DSM‐IV TR Classification of MDD as treatment‐resistant. No brain structural abnormalities as evidenced by an MRI scan Signed acceptance of Informed Consent Exclusion criteria Other psychiatric diagnosis apart from MDD Substance abuse or dependence (prior or during study) Pregnancy Congestive heart disease Personal history of psychosis First‐degree relative with history of psychosis Glaucoma Present neurological disease High blood or pulmonary artery pressure Declining the signing of the informed consent
Interventions	Ketamine versus placebo
Outcomes	Primary outcome measures: changes in baseline HRSD Score. Time frame: 20 minutes before and 40 minutes after ketamine infusion. [Designated as safety issue: no]. The HRSD baseline score will be measured 20 minutes before ketamine infusion. After 40 minutes post‐infusion, a second HRSD score will be obtained
Starting date	September 2013
Contact information	mailto:paul%40lamothe.com?subject=NCT01868802, ABC KET‐DRT‐01‐2013, Ketamine for Treatment‐resistant Depression: A Multicentric Clinical Trial in Mexican Population
Notes	NCT01868802