Trial | NCT01868802  Report issue

Official Title

Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ketamine ...

  • Study Participants

    60
A randomized 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. The purpose of this study is to determine whether clinical response seen in previous studies is replicable in this population.
Study Started
Sep 30
2013
Primary Completion
May 31
2016
Anticipated
Last Update
Mar 17
2015
Estimate

Drug Ketamine

A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.

  • Other names: Ketalar

Drug Placebo

Saline at 0.9% intravenous infusion will be administered over 40 minutes.

Ketamine treated Experimental

Control, placebo treated Placebo Comparator

Criteria 

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.
No Results Posted