A Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of (R)-Ketamine Hydrochloride Nasal Spray in Patients With Depression and Acute Suicidal Ideation or Behavior

Recruiting Phase 2 Interventional Study
Major Depressive Disorder (MDD
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 64
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
98 (estimated)
Sponsor
Sichuan Purity Pharmaceutical Technology Co., Ltd. · Industry
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About This Trial
The purpose of this study is to learn about: * To evaluate the efficacy of PRT-042 nasal spray for the Rapid Reduction of the depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior * To evaluate the safety and pharmacokinetic (PK) characteristics after multiple dose of PRT-042 nasal spray in adults with major depressive disorder (MDD) with acut…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for Major Depressive Disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Mini International Psychiatric Interview …
Contacts

ke yao

86-028-85170738

ke.yao@btyy.com

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