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

March 13, 2015 updated by: Paul J. Lamothe
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Paul J Lamothe, M.D.
  • Phone Number: +52 (55) 11031750
  • Email: paul@lamothe.com

Study Contact Backup

Study Locations

  • Mexico
    • DF
      • Mexico City, DF, Mexico, 05300
        • Recruiting
        • ABC Neurological Center
        • Contact:
        • Principal Investigator:
          • Paul J Lamothe Molina, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine treated
Drug: Ketamine
A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.
Other Names:
  • Ketalar
Placebo Comparator: Control, placebo treated
Drug: Placebo
Saline at 0.9% intravenous infusion will be administered over 40 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in baseline HDRS Score
Time Frame: 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.
20 minutes before and 40 minutes after ketamine infusion.
Daily change in HDRS post-ketamine infusion.
Time Frame: 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.
1,2,3,4,5,6 and 7. Days after ketamine infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline blood pressure (BP).
Time Frame: 20 minutes before ketamine infusion.
Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion.
20 minutes before ketamine infusion.
Changes from baseline in blood pressure (BP)
Time Frame: 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.
every 5 minutes in a 300 minutes period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul J. Lamothe

Investigators

  • Principal Investigator: Paul J Lamothe, M.D., American British Cowdray Medical Center
  • Study Director: David N Lopez-Garza, M.D., American British Cowdray Medical Center
  • Principal Investigator: Manuel Ruiz-Alvarez, M.D., American British Cowdray Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 13, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABC KET-DRT-01-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Treatment-Resistant Depression

Clinical Trials on Ketamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe