Major depression disorder. Major depressive disorder, single episode, unspecified.
Conditions
Interventions
Intervention 1: Intervention group: 0.7mg/kg racemic ketamine hydrochloride via intranasal spray over 20 minutes, and simultaneously received an intravenous infusion of 0.9% saline solution (placebo)
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age above 18 years old Diagnosis of Major Depressive Disorder according to DSM-IV criteria by a study psychiatrist, currently in the active phase of the illness. A score of >= 24 on the IDS-C30 (Inventory of Depressive Symptoms–Clinician).
Exclusion criteria
Exclusion criteria: Pregnancy in women Any unstable medical or neurological condition Positive urine test for illicit drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the severity of depression symptoms. Timepoint: 24 hours after administration of the drug. Method of measurement: Changes in the Montgomery-Åsberg Depression Rating Scale (MADRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the level of anxiety. Timepoint: 24 hours after the administration. Method of measurement: changes in Hamilton Anxiety Rating Scale (HAM-A) score.;Safety and tolerance of the drug. Timepoint: during administration and recovery phase. Method of measurement: changes in vital signs, BPRS+ (The Brief Psychiatric Rating Scale–Positive Subscale) score and the Clinician-Administered Dissociative States Scale (CADSS) score. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra Shenasandeh
Shahid Beheshti University of Medical Sciences
Outcome results
None listed