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
NCT ID: NCT07193901
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
98 participants
INTERVENTIONAL
2025-05-27
2026-06-30
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low Dose PRT042 nasal spray
Low Dose PRT042 nasal spray
two times a week, for 4 weeks
median Dose PRT042 nasal spray
median Dose PRT042 nasal spray
two times a week, for 4 weeks
high Dose PRT042 nasal spray
high dose PRT042 nasal spray
two times a week, for 4 weeks
placebo
placebo
two times a week, for 4 weeks
Interventions
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Low Dose PRT042 nasal spray
two times a week, for 4 weeks
median Dose PRT042 nasal spray
two times a week, for 4 weeks
high dose PRT042 nasal spray
two times a week, for 4 weeks
placebo
two times a week, for 4 weeks
Eligibility Criteria
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Inclusion Criteria
2. Participants must have current suicidal ideation with intent, confirmed by a "Yes" response to Question B3 \[Think (even momentarily) about harming or of hurting or of injuring yourself: with at least some intent or awareness that you might die as a result; or think about suicide (ie, about killing yourself)?\] and Question B10 \[Intend to act on thoughts of killing yourself?\] obtained from the MINI.
3. Participant has a Montgomery Asberg Depression Rating Scale (MADRS) total score of greater than (≥) 28 and the score for item 10"suicide ideation" of greater than (≥) 3 predose on Day 1
Exclusion Criteria
2. Participant has a current clinical diagnosis of autism, dementia, or intellectual disability.
3. Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features .
4. Participant meets the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder, within the 6 months before screening
5. Participant has a current or prior diagnosis of a reatment resistant depression
6. Any nasal conditions or diseases that, in the investigator's judgment, may significantly affect the administration or absorption of a nasal product.
7. Participant has a history of malignancy within 5 years before screening
8. Pregnant or breastfeeding women, or those with a positive pregnancy test result during screening.
9. Previous participation in another clinical trial and receiving the investigational drug within 3 months prior to dosing.
18 Years
64 Years
ALL
No
Sponsors
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Sichuan Purity Pharmaceutical Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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BEIjing AnDing hospital capital medical university
Beijing, , China
Beijing AnDing hospital capital medical university
Beijing, , China
Beijing Huilongguan Hospital
Beijing, , China
The Fourth People's Hospital of Chengdu
Chengdu, , China
Hangzhou Seventh People's Hospital
Hangzhou, , China
The fourth affiliated hospital of Anhui medical university
Hefei, , China
The affiliated Kangning Hospital of Ningbo University
Ningbo, , China
Suzhou Guangji Hospital
Suzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Wei Wang
Role: primary
Fude Yang
Role: primary
Feiyan Wang
Role: primary
Tao Li
Role: primary
Zhonglin Tan
Role: backup
Huanzhong Liu
Role: primary
Yongming Xu
Role: primary
Yansong Liu
Role: primary
Other Identifiers
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PRT042-II-01
Identifier Type: -
Identifier Source: org_study_id
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