Controlled study of esketamine treatment for depression with suicidal ideation based on near-infrared spectroscopy
This parallel, controlled Phase 4 trial (n=60) in China is evaluating intravenous esketamine for adults with depression and suicidal ideation. Participants are allocated to an observation group receiving esketamine infusion or a control group treated with a selective serotonin reuptake inhibitor (SSRI). The study is designed to assess the clinical effects of esketamine in this high-risk population, with outcomes measured using the Hamilton Rating Scale for Depression (HAMD-17) and the Columbia-Suicide Severity Rating Scale (C-SSRS). These primary outcomes focus on changes in depressive symptoms and suicidality, although the specific assessment timepoints are not provided in the trial record. A secondary outcome is frontal lobe oxygenated haemoglobin concentration measured by near-infrared brain imaging, suggesting an interest in correlating symptomatic improvement with changes in cerebral haemodynamics. The trial is sponsored by Huzhou Third Municipal Hospital. As a registered Chinese interventional study, it adds to the growing body of clinical research examining esketamine as a rapid-acting treatment option for depression with suicidal ideation.
Study Arms & Interventions
Experimental
experimentalcontrol group:selective serotonin reuptake inhibitor,SSRI;Observation group:Intravenous infusion of esketamine;
Interventions
- Esketamine
Extracted from ChiCTR intervention description
Participants
Inclusion Criteria
- Inclusion criteria: 1.ASA I~II level patients;2.Patients aged 18-65, gender not limited;3.Patients with HAMD17 score >=17;4.Patients rated as high risk or very high risk by C-SSRS.
Exclusion Criteria
- Exclusion criteria: 1.Patients allergic to any component of esketamine;2.Patients with a serious risk of hypertension or increased intracranial pressure, and with uncontrolled or untreated hypertension (arterial hypertension, resting systolic/diastolic blood pressure exceeding 180/100mmHg);3.Pregnant or breastfeeding women;4.Patients with severe diseases of important organs such as heart, brain, liver, and kidney;5.Obese patients or with severe snoring;6.Patients with hyperthyroidism;7.Patients with other serious mental illnesses.
Study Details
- StatusNot yet recruiting
- PhasePhase IV
- Typeinterventional
- DesignNon-randomized
- TimelineStart: 2025-02-01
- Compound
- Topics