Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2013
CompletedFirst Posted
Study publicly available on registry
June 5, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedMarch 17, 2015
March 1, 2015
2.7 years
May 24, 2013
March 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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
Secondary Outcomes (2)
Baseline blood pressure (BP).
20 minutes before ketamine infusion.
Changes from baseline in blood pressure (BP)
every 5 minutes in a 300 minutes period
Study Arms (2)
Ketamine treated
EXPERIMENTALControl, placebo treated
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Paul J. Lamothelead
Study Sites (1)
ABC Neurological Center
Mexico City, Mexico City, 05300, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief of the Research Department, Neurological Center.
Study Record Dates
First Submitted
May 24, 2013
First Posted
June 5, 2013
Study Start
September 1, 2013
Primary Completion
May 1, 2016
Last Updated
March 17, 2015
Record last verified: 2015-03