PRT-042 (R‑ketamine) nasal spray for adults with depression and acute suicidal thoughts or behavior

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

This will test whether PRT-042 (R‑ketamine) nasal spray can quickly reduce depressive symptoms and suicidal thoughts in adults with major depressive disorder who currently have acute suicidal ideation or behavior.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd. (industry)
• Locations: 8 sites (Beijing and 7 other locations)
• Trial ID: NCT07193901 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study gives adults with major depressive disorder and current suicidal ideation or behavior repeated doses of PRT-042 nasal spray at low, medium, or high dose or placebo and measures changes in depressive symptoms and suicidal ideation. Eligibility requires a MINI-confirmed MDD diagnosis, a MADRS total score ≥28, and a MADRS suicide item score ≥3, with suicidality confirmed on the MINI. The study also collects safety data and pharmacokinetic (PK) measurements after multiple dosing to characterize drug exposure. Outcomes will focus on rapid symptom reduction as well as tolerability and PK profiles.

Who should consider this trial

Good fit: Adults with major depressive disorder without psychotic features who currently have acute suicidal ideation or behavior, meet MINI diagnostic criteria, and have a MADRS total score ≥28 with a high suicide item score are the intended participants.

Not a fit: People with bipolar disorder, primary psychotic disorders, or those who do not currently have significant suicidal ideation are unlikely to meet eligibility or to benefit from this specific intervention.

Why it matters

Potential benefit: If successful, PRT-042 could offer a fast-acting nasal treatment to reduce severe depressive symptoms and suicidal thoughts in high-risk patients.

How similar studies have performed: Other rapid-acting NMDA-receptor modulators such as intravenous ketamine and intranasal esketamine have shown fast reductions in depressive symptoms and suicidal ideation, but R‑ketamine nasal spray has been less tested in humans.

Eligibility criteria

Inclusion Criteria:

1. 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) .
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:

1. Participant has a current DSM-5 diagnosis of bipolar (or related disorders), antisocial personality disorder, or obsessive compulsive disorder.
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.

Where this trial is running

Beijing and 7 other locations

• BEIjing AnDing hospital capital medical university — Beijing, China (RECRUITING)
• Beijing AnDing hospital capital medical university — Beijing, China (RECRUITING)
• Beijing Huilongguan Hospital — Beijing, China (RECRUITING)
• The Fourth People's Hospital of Chengdu — Chengdu, China (RECRUITING)
• Hangzhou Seventh People's Hospital — Hangzhou, China (RECRUITING)
• The fourth affiliated hospital of Anhui medical university — Hefei, China (RECRUITING)
• The affiliated Kangning Hospital of Ningbo University — Ningbo, China (RECRUITING)
• Suzhou Guangji Hospital — Suzhou, China (RECRUITING)

Study contacts

• Study coordinator: ke yao

Conditions: Major Depressive Disorder (MDD