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

Treatment-Resistant Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01868802
• Other study ID #: ABC KET-DRT-01-2013
• Status: Recruiting
• Phase: Phase 2
• First received: May 24, 2013
• Last updated: March 13, 2015
• Start date: September 2013

Study information

• Verified date: March 2015
• Source: American British Cowdray Medical Center
• Contact: Paul J Lamothe, M.D.
• Phone: +52 (55) 11031750
• Email: paul[@]lamothe.com
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder,
• Depressive Disorder, Treatment-Resistant
• Treatment-Resistant Depression

Intervention

Drug:
• Ketamine
A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.
• Placebo
Saline at 0.9% intravenous infusion will be administered over 40 minutes.

Locations

Country	Name	City	State
Mexico	ABC Neurological Center	Mexico City	DF

Sponsors (1)

Lead Sponsor	Collaborator
Paul J. Lamothe

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in baseline HDRS Score	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.	20 minutes before and 40 minutes after ketamine infusion.	No
Primary	Daily change in HDRS post-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.	1,2,3,4,5,6 and 7. Days after ketamine infusion	No
Secondary	Baseline blood pressure (BP).	Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion.	20 minutes before ketamine infusion.	Yes
Secondary	Changes from baseline in blood pressure (BP)	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.	every 5 minutes in a 300 minutes period	Yes