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Completed

NCT Number: NCT07193901

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

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

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Key information

Conditions

Major Depressive Disorder (MDD Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Sixth Hospital of Peking University, Beijin, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Low Dose PRT042 nasal spray

Drug

two times a week, for 4 weeks

median Dose PRT042 nasal spray

Drug

two times a week, for 4 weeks

high dose PRT042 nasal spray

Drug

two times a week, for 4 weeks

Placebo

Drug

two times a week, for 4 weeks

Primary outcomes

  1. Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours After the First Dose (Day 2)

    Time frame: Baseline (Day 1, predose) and 24 hours first post dose (Day 2)

    The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.

Secondary outcomes

  1. Change From Baseline in Montgomery Asberg Depression Rating Scale Total Score During Double-blind Phase

    Time frame: Days 1 (4 hours postdose), 4, 8, 11, 15, 18, 22 and Day 25

    The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.

  2. Number of Participants who Achieved Response （≥50% decrease from baseline MADRS total score）Through the Double-blind Phase

    Time frame: Days 1 (4 hours postdose),2, 4, 8, 11, 15, 18, 22 and Day 25

  3. Number of Participants Who Achieved Remission (MADRS Total Score Less Than or Equal to [<=] 12) Through the Double-blind Phase

    Time frame: Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and Day 25

  4. 5. Change From Baseline in Clinical Global Impression- Severity of Suicidality-Revised (CGI-SS-R) During Double-blind Phase

    Time frame: Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and Day 25

    CGI-SS-R was derived from the Clinical Global Impression Severity Scale (CGI-S), a global rating scale that gives an overall measure of the severity of a participants illness. The CGI-SS-R rating is scored on a 7-point scale from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal participants). A higher score indicates a more severe condition and a reduction in score indicates improvement (that is, lower severity of suicidality).

  5. Number of Participants Who Achieved Resolution of Suicidality (CGI-SS-R Score of 0 or 1) Through Double-blind Phase

    Time frame: up to Day 25

  6. Change From Baseline in Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I) Scale Total Score During Double-blind Phase

    Time frame: Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and Day 25

    The CGI-SR-I is a scale summarizing the clinician's best assessment of the likelihood that the participant will attempt suicide in the next 7 days. The CGI-SR-I rating is scored on a 7-point scale: where' 0 (no imminent suicide risk); 1 (minimal imminent suicide risk), 2 (mild imminent suicide risk), 3 (moderate imminent suicide risk), 4 (marked imminent suicide risk), 5 (severely imminent suicide risk), 6 (extreme imminent suicide risk). Higher score indicates a more severe condition. Negative change in score indicates improvement.

  7. 8. Change From Baseline in Beck Hopelessness Scale (BHS) Total Score During Double-blind Phase

    Time frame: Baseline, Days 8 ,15 and 25

    BHS is a self-reported measure to assess one's level of negative expectations or pessimism regarding future. It consists of 20 true-false items that examine respondent's attitude over past week by either endorsing a pessimistic statement or denying an optimistic statement; 9 are keyed false and 11 are keyed true. For every statement, each response was assigned score of 0 or 1. Total BHS score is sum of item responses, ranged from 0-20, where higher score represented higher level of hopelessness.

  8. Change From Baseline in Beck Scale for Suicide Ideation -Chinese Version (BSI-CV) Total Score During Double-blind Phase

    Time frame: Baseline, Days 8 ,15 and 25

    BSI-CV is a self-reported measure with 19 items, scored on a 3-point scale (0 to 2). The final score ranges from 0 to 38, with higher scores indicating a greater likelihood of suicide.

  9. Number of Participants With Treatment Emergent Adverse Events (TEAEs)、Vital Signs Abnormalities、Abnormal Electrocardiogram (ECG) Values et al: DB Treatment Phase

    Time frame: up to Day 25

  10. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])

    Time frame: up to Day 25

  11. Maximum Plasma Concentration [Cmax]

    Time frame: up to Day 25

  12. plasma elimination half-life [T1/2]

    Time frame: up to Day 25

Sponsors and collaborators

Lead sponsor

Sichuan Purity Pharmaceutical Technology Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Phase Il 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2025
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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