A Study on the Rapid Antisuicidal Mechanism and Therapeutic Efficacy Prediction of Ketamine Based on Glu/GABA Metabolism in the Prefrontal-Limbic System Circuit
This non-randomised controlled interventional study (n=199) in China is evaluating the rapid anti-suicidal effects and mechanistic correlates of ketamine in adults aged 18 to 65 with major depressive disorder, with a focus on those with suicidal ideation. Participants are assigned to a major depressive disorder group without suicidal ideation (n=50, no intervention) or a major depressive disorder group with suicidal ideation (n=149) receiving intravenous ketamine. The trial is designed to investigate how ketamine influences glutamate/GABA metabolism within prefrontal-limbic circuit networks, and to identify neuroimaging markers associated with treatment response. The primary outcomes are neuroimaging-based and include comparisons between participants whose suicidal ideation decreases versus those whose ideation remains unchanged, imaging changes within the ketamine-treated group before and after treatment, and neuroimaging features that may predict ketamine’s anti-suicidal effect. Secondary outcomes assess correlations between neuroimaging features and individual symptom scores, including MADRS and HAMD ratings. The study is sponsored by Beijing Anding Hospital, Capital Medical University, and is currently pending. No phase designation or ketamine dose has been provided.
Study Arms & Interventions
Experimental
experimentalmajor depressive disorder without suicidal ideation:none;major depressive disorder with suicidal ideation:Intravenous injection of ketamine;
Interventions
- Ketamine
Extracted from ChiCTR intervention description
Participants
Inclusion Criteria
- Inclusion criteria: 1. Meets the diagnostic criteria for a depressive episode in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), either first episode or recurrence, without psychotic symptoms.2. Aged 18 to 65; gender unrestricted; Han ethnicity; right-handed.3. With or without suicidal ideation: A score of >=6 on the Beck Scale for Suicide Ideation (BSS) was used as the criterion for the presence of suicidal ideation.4. No contraindications to MRI scans such as electronic and metal device implants;5. Sign the informed consent form;
Exclusion Criteria
- Exclusion criteria: 1. Current or past diagnoses that meet the criteria of other significant conditions in DSM-5, excluding depressive disorders, include schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, disruptive impulse control and conduct disorders;2. There are serious organic diseases or medical histories of important systems or organs;3. Having evidence of drug dependence and use of psychoactive substances;4. Pregnant or lactating female patients;5. The researchers determined that those with poor compliance or who were not suitable for participation;6. Those with metal implants or dentures in their bodies, pregnant or lactating women, and those with claustrophobia, etc., cannot undergo MRI scans;
Study Details
- StatusNot yet recruiting
- PhasePhase NA
- Typeinterventional
- DesignRandomized
- TimelineStart: 2025-09-20
- Compound
- Topics