search
Back to results

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

Primary Purpose

Depressive Disorder,, Treatment-Resistant Depression

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
Paul J. Lamothe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, focused on measuring Ketamine, Depression, Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • ABC Neurological CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamine treated

Control, placebo treated

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Baseline blood pressure (BP).
Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion.
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.

Full Information

First Posted
May 24, 2013
Last Updated
March 13, 2015
Sponsor
Paul J. Lamothe
search

1. Study Identification

Unique Protocol Identification Number
NCT01868802
Brief Title
Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
Official Title
Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paul J. Lamothe

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder,, Treatment-Resistant Depression
Keywords
Ketamine, Depression, Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine treated
Arm Type
Experimental
Arm Title
Control, placebo treated
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline at 0.9% intravenous infusion will be administered over 40 minutes.
Primary Outcome Measure Information:
Title
Changes in baseline HDRS Score
Description
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.
Time Frame
20 minutes before and 40 minutes after ketamine infusion.
Title
Daily change in HDRS post-ketamine infusion.
Description
On a daily basis, from day 1-7 post-ketamine infusion, changes in HDRS score will be measured during the daily psychiatric evaluation.
Time Frame
1,2,3,4,5,6 and 7. Days after ketamine infusion
Secondary Outcome Measure Information:
Title
Baseline blood pressure (BP).
Description
Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion.
Time Frame
20 minutes before ketamine infusion.
Title
Changes from baseline in blood pressure (BP)
Description
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.
Time Frame
every 5 minutes in a 300 minutes period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul J Lamothe, M.D.
Phone
+52 (55) 11031750
Email
paul@lamothe.com
First Name & Middle Initial & Last Name or Official Title & Degree
David N Lopez-Garza, M.D.
Phone
+ 52 (55) 11031750
Email
davidlopezgarza@prodigy.net.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Lamothe, M.D.
Organizational Affiliation
American British Cowdray Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David N Lopez-Garza, M.D.
Organizational Affiliation
American British Cowdray Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Manuel Ruiz-Alvarez, M.D.
Organizational Affiliation
American British Cowdray Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
ABC Neurological Center
City
Mexico City
State/Province
DF
ZIP/Postal Code
05300
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo San Esteban, M.D.
Phone
+52 (55) 52308000
Email
esanesteban@hotmail.com
First Name & Middle Initial & Last Name & Degree
Paul J Lamothe Molina, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs