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

Phase 2

• Conditions: Depressive Disorder,; Treatment-Resistant Depression
• Interventions: Drug: Placebo; Drug: Ketamine

• Registration Number: NCT01868802
• Lead Sponsor: Paul J. Lamothe

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-05
• Study Start: 2013-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-03-17
• Primary Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control, placebo treated	Placebo	-
Ketamine treated	Ketamine	-

Primary Outcome Measures

Name	Time	Method
Changes in baseline HDRS Score	20 minutes before and 40 minutes after ketamine infusion.	The Hamilton Depression Rating Scale (HDRS) baseline score will be measured 20 minutes before ketamine infusion. After 40 minutes post-infusion, a second HDRS score will be obtained.
Daily change in HDRS post-ketamine infusion.	1,2,3,4,5,6 and 7. Days after ketamine infusion	On a daily basis, from day 1-7 post-ketamine infusion, changes in HDRS score will be measured during the daily psychiatric evaluation.

Secondary Outcome Measures

Name	Time	Method
Baseline blood pressure (BP).	20 minutes before ketamine infusion.	Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion.
Changes from baseline in blood pressure (BP)	every 5 minutes in a 300 minutes period	BP will be monitored continuously for a 4-hour period. BP assessments will be taken every five minutes for the period mentioned. The assessment will start 20 minutes before ketamine administration and will finish 4hrs after starting.

Trial Locations

Locations (1)

ABC Neurological Center; 🇲🇽 Mexico City, DF, Mexico