Depressive Disorder,, Treatment-Resistant Depression
Conditions
Keywords
Ketamine, Depression, Depressive Disorder
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.
Interventions
DRUGKetamine
A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.
DRUGPlacebo
Saline at 0.9% intravenous infusion will be administered over 40 minutes.
Sponsors
Paul J. Lamothe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in baseline HDRS Score | 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. |
| Daily change in HDRS post-ketamine infusion. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline blood pressure (BP). | 20 minutes before ketamine infusion. | Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion. |
| Changes from baseline in blood pressure (BP) | 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. |
Countries
Mexico
Contacts
Primary ContactPaul J Lamothe, M.D.
Backup ContactDavid N Lopez-Garza, M.D.
Outcome results
None listed