AzTrials
AzTrials

Major Depressive Disorder (MDDPhase 2NCT07193901

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

A Phase 2 study testing Low Dose PRT042 nasal spray, median Dose PRT042 nasal spray and high dose PRT042 nasal spray in people with Major Depressive Disorder (MDD, run by Sichuan Purity Pharmaceutical Technology Co., Ltd. at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 acute suicidal ideation or behavior To evaluate the safety and pharmacokinetic (PK) characteristics after multiple dose of… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Major Depressive Disorder (MDD
What is being tested?
Low Dose PRT042 nasal spray, median Dose PRT042 nasal spray and high dose PRT042 nasal spray
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
15 sitesChina
Study dates
27 May 2025to 1 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • The Sixth Hospital of Peking University

    Beijin

  • BEIjing AnDing hospital capital medical university

    Beijing

  • Beijing Huilongguan Hospital

    Beijing

  • Brain Hospital of Hunan Province

    Changsha

  • The Second Xiangya Hospital of Central South University

    Changsha

  • The Fourth People's Hospital of Chengdu

    Chengdu

  • Hangzhou Seventh People's Hospital

    Hangzhou

  • Hefei Fourth People's Hospital(Anhui Mental Health Prevention and Treatment Center)

    Hefei

  • The fourth affiliated hospital of Anhui medical university

    Hefei

  • The Affiliated Hospital of Southwest Medical University

    Luzhou

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • The affiliated Kangning Hospital of Ningbo University

    Ningbo

  • Suzhou Guangji Hospital

    Suzhou

  • Wuxi Mental Health Center

    Wuxi

  • Zhumadian Second People's Hospital(Zhumadian Psychiatric Hospital )

    Zhumadian

Other trials in China

About this study

Official 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

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
Being tested
Low Dose PRT042 nasal spray, median Dose PRT042 nasal spray, high dose PRT042 nasal spray, placebo
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Dose PRT042 nasal sprayDrug

    two times a week, for 4 weeks

  • median Dose PRT042 nasal sprayDrug

    two times a week, for 4 weeks

  • high dose PRT042 nasal sprayDrug

    two times a week, for 4 weeks

  • placeboDrug

    two times a week, for 4 weeks

Study groups in NCT07193901
Study groupRoleWhat they receive
Low Dose PRT042 nasal sprayExperimentalNot described
Receives: Drug: Low Dose PRT042 nasal spray
median Dose PRT042 nasal sprayExperimentalNot described
Receives: Drug: median Dose PRT042 nasal spray
high Dose PRT042 nasal sprayExperimentalNot described
Receives: Drug: high dose PRT042 nasal spray
placeboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (12)

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

    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.

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

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

    Measured: 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

    Measured: 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

    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).

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

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

    Measured: 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

    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.

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

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

    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.

    Measured: Baseline, Days 8 ,15 and 25

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

    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.

    Measured: Baseline, Days 8 ,15 and 25

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

    Measured: up to Day 25

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

    Measured: up to Day 25

  11. Maximum Plasma Concentration [Cmax]

    Measured: up to Day 25

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

    Measured: up to Day 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2025
  2. Study start27 May 2025
  3. Primary completion10 Apr 2026
  4. Study completion1 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07193901
Sponsor's protocol ID
PRT042-II-01
Status last verified
Sep 2026
First submitted
1 Sep 2025
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low Dose PRT042 nasal spray, median Dose PRT042 nasal spray and high dose PRT042 nasal spray in people with Major Depressive Disorder (MDD, run by Sichuan Purity Pharmaceutical Technology Co., Ltd. at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07193901.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in