Major Depressive Disorder
Conditions
Brief summary
The current study wishes to contribute to the applicability of the use of ketamine in a clinical setting by focusing on the efficacy of intra-nasal administration compared with the IV route.
Interventions
DRUGPlacebo
Saline 0.9%, Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)
DRUGKetamine (1st phase)
Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)
DRUGKetamine (2st phase)
Patients failing to achieve response (\<50% MADRS score) in the parallal phase, will be offered additional 4 session (twice a week, 2 weeks) of 0.5 mg/kg ketamine over 40 minutes.
Sponsors
Shalvata Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-65 2. Diagnosis of MDD (Major Depressive Disorder), made or affirmed by a senior psychiatrist in Shalvata 3. MADRS score \> 20 4. Treated with conventional anti-depressant, administered within a formal psychiatric clinic or by a certified psychiatrist.
Exclusion criteria
1. Active or past psychotic disorder, including a history of psychotic affective state 2. Mental Retardation or Autistic Spectrum Disorder 3. Prominent personality disorder 4. Cardiac or neurologic active medical condition, including past CVA/TIA (Cardiovascular Accident/Transient Ischemic Attack) or any other unstable medical condition. 5. Chronic nasal congestion 6. Active or recent drug or alcohol abuse 7. Substantial suicidality in a patient requiring admission but refuses to do so, and signs an against medical advice release form as part of clinical evaluation, and does not answer the terms for involuntary admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline | 15 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of subjects achieving remission | 15 weeks | — |
| Ratio of subjects achieving Response | 15 weeks | — |
| Durability of anti-depressant effect according to MADRS Score | 15 weeks | The rate of effect decline, as measured by MADRS Questionnaire |
| Tolerability of Route, based on side effects questionnaire | 3 weeks | Adverse side effects reported by subjects, as reported in side effects questionnaire |
Countries
Israel
Outcome results
None listed