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Also known as Ketamine hydrochloride
SLS-002 · 1 trial · 2 indications
MADRS is clinician-rated scale designed to be used in participants with Major Depressive Disorder (MDD) to measure depression severity and detect changes due to antidepressant treatment. It evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic and suicidal thoughts. Scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), summed for total possible score of 0 to 60.
| Arm | Type | Description |
|---|---|---|
| SLS-002 + Standard of care | EXPERIMENTAL | Participants will receive SLS-002 (intranasal racemic ketamine) 90 milligram (mg) two times per week for 2 weeks with standard of care treatment |
| Placebo + Standard of care | PLACEBO_COMPARATOR | Participants will receive intranasal placebo two times per week for 2 weeks with standard of care treatment |
| Name | Type | Description |
|---|---|---|
| SLS-002 | DRUG | Intranasal racemic ketamine hydrochloride 90 milligrams (mg) |
| Placebo | DRUG | Intranasal placebo |
| Standard of care | OTHER | Standard of care treatment will be determined by the treating physician(s) based on clinical judgement and practice guidelines |
| Intranasal device | DEVICE | Device to deliver intranasal solution |
Inclusion Criteria: * Participant with diagnosis of current MDD (unipolar without psychotic features) per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with symptoms present for at least 4 weeks, based on psychiatric intake and confirmed by the Mini International Psy...