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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
Led by Sichuan Purity Pharmaceutical Technology Co., Ltd. · Updated on 2026-01-22
98
Participants Needed
8
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
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 acute suicidal ideation or behavior
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 64 years
- Meet DSM-5 criteria for Major Depressive Disorder without psychotic features confirmed by MINI
- Current suicidal thoughts with intent confirmed by MINI questions B3 and B10
- Montgomery Asberg Depression Rating Scale (MADRS) total score of at least 29 and item 10 score of at least 4 before dosing on Day 1
You will not qualify if you...
- Current diagnosis of bipolar disorder, antisocial personality disorder, or obsessive compulsive disorder
- Current clinical diagnosis of autism, dementia, or intellectual disability
- Current or past diagnosis of psychotic disorder or MDD with psychotic features
- Moderate or severe substance or alcohol use disorder within 6 months before screening
- Current or past treatment-resistant depression
- Nasal conditions that may affect nasal spray absorption
- History of cancer within 5 years before screening
- Pregnant or breastfeeding or positive pregnancy test during screening
- Participation in another clinical trial with investigational drug within 3 months prior to dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
BEIjing AnDing hospital capital medical university
Beijing, China
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2
Beijing AnDing hospital capital medical university
Beijing, China
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3
Beijing Huilongguan Hospital
Beijing, China
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4
The Fourth People's Hospital of Chengdu
Chengdu, China
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5
Hangzhou Seventh People's Hospital
Hangzhou, China
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6
The fourth affiliated hospital of Anhui medical university
Hefei, China
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7
The affiliated Kangning Hospital of Ningbo University
Ningbo, China
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8
Suzhou Guangji Hospital
Suzhou, China
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Research Team
K
ke yao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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