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Nasal spray could rapidly ease depression and suicidal urges

NCT ID NCT07193901

Symptom relief Sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This study tests a nasal spray containing (R)-Ketamine, a fast-acting drug, in 98 adults with major depression who are currently having suicidal thoughts. Participants receive either the spray or a placebo twice a week for 4 weeks. The goal is to see if the spray can quickly reduce depression symptoms and suicidal behavior, and to check its safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
(R)-Ketamine hydrochloride nasal spray
What this could lead to
If it works, this could provide a fast-acting treatment to quickly reduce severe depression and suicidal thoughts, potentially saving lives.
What could go wrong
This is an early Phase 2 trial with only 98 participants, so results may not apply broadly. The drug may cause side effects or fail to outperform placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

98 people

The number who actually took part.

Started

May 2025

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder (MDD)

Contacts and locations

Locations

  • BEIjing AnDing hospital capital medical university

    Beijing, China

  • Beijing Huilongguan Hospital

    Beijing, China

  • Brain Hospital of Hunan Province

    Changsha, China

  • Hangzhou Seventh People's Hospital

    Hangzhou, China

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

    Hefei, China

  • Suzhou Guangji Hospital

    Suzhou, China

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, China

  • The Fourth People's Hospital of Chengdu

    Chengdu, China

  • The Second Xiangya Hospital of Central South University

    Changsha, China

  • The Sixth Hospital of Peking University

    Beijin, China

  • The affiliated Kangning Hospital of Ningbo University

    Ningbo, China

  • The fourth affiliated hospital of Anhui medical university

    Hefei, China

  • Wuxi Mental Health Center

    Wuxi, China

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

    Zhumadian, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.