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
Recruiting · NCT07193901 · Interventional (participants receive a specific treatment) · Lead sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Low Dose PRT042 nasal sprayhigh dose PRT042 nasal spraymedian Dose PRT042 nasal sprayplacebo
What this trial is about
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
Who can take part
Age range
18 Years to 64 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
8 locations listed.
- BEIjing AnDing hospital capital medical university - Beijing, China
- Beijing AnDing hospital capital medical university - Beijing, China
- Beijing Huilongguan Hospital - Beijing, China
- The Fourth People's Hospital of Chengdu - Chengdu, China
- Hangzhou Seventh People's Hospital - Hangzhou, China
- The fourth affiliated hospital of Anhui medical university - Hefei, China
- The affiliated Kangning Hospital of Ningbo University - Ningbo, China
- Suzhou Guangji Hospital - Suzhou, China