Status:
RECRUITING
A Study to Assess the Efficacy and Safety of PRT-042 Nasal Spray for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Participants Who Are Assessed to be at Imminent Risk for Suicide
Lead Sponsor:
Sichuan Purity Pharmaceutical Technology Co., Ltd.
Conditions:
Major Depressive Disorder (MDD
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- 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 (MINI) .
- 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.
- 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
- Participant has a current DSM-5 diagnosis of bipolar (or related disorders), antisocial personality disorder, or obsessive compulsive disorder.
- Participant has a current clinical diagnosis of autism, dementia, or intellectual disability.
- Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features .
- Participant meets the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder, within the 6 months before screening
- Participant has a current or prior diagnosis of a reatment resistant depression
- Any nasal conditions or diseases that, in the investigator's judgment, may significantly affect the administration or absorption of a nasal product.
- Participant has a history of malignancy within 5 years before screening
- Pregnant or breastfeeding women, or those with a positive pregnancy test result during screening.
- Previous participation in another clinical trial and receiving the investigational drug within 3 months prior to dosing.
Key Trial Info
Start Date :
May 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT07193901
Start Date
May 27 2025
End Date
June 1 2026
Last Update
September 26 2025
Active Locations (8)
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1
BEIjing AnDing hospital capital medical university
Beijing, China
2
Beijing AnDing hospital capital medical university
Beijing, China
3
Beijing Huilongguan Hospital
Beijing, China
4
The Fourth People's Hospital of Chengdu
Chengdu, China