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

Paul J. Lamothe

Status and phase: Unknown; Phase 2

Conditions: Depressive Disorder,; Treatment-Resistant Depression

Treatments: Drug: Placebo; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01868802

ABC KET-DRT-01-2013

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Ketamine treated

Experimental group

Treatment:

Drug: Ketamine

Control, placebo treated

Placebo Comparator group

Treatment:

Drug: Placebo