Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
Information source: American British Cowdray Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder,; Treatment-Resistant Depression
Intervention: Ketamine (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Paul J. Lamothe Official(s) and/or principal investigator(s):
Paul J Lamothe, M.D., Principal Investigator, Affiliation: American British Cowdray Medical Center
David N Lopez-Garza, M.D., Study Director, Affiliation: American British Cowdray Medical Center
Manuel Ruiz-Alvarez, M.D., Principal Investigator, Affiliation: American British Cowdray Medical Center
Overall contact:
Paul J Lamothe, M.D., Phone: +52 (55) 11031750, Email: paul@lamothe.com
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.
Clinical Details
Official title: Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Changes in baseline HDRS ScoreDaily change in HDRS post-ketamine infusion.
Secondary outcome: Baseline blood pressure (BP).Changes from baseline in blood pressure (BP)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Paul J Lamothe, M.D., Phone: +52 (55) 11031750, Email: paul@lamothe.com
ABC Neurological Center, Mexico City, DF 05300, Mexico; Recruiting
Eduardo San Esteban, M.D., Phone: +52 (55) 52308000, Email: esanesteban@hotmail.com
Paul J Lamothe Molina, M.D., Principal Investigator
Additional Information
Starting date: September 2013
Last updated: March 13, 2015
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