Skip to main content

Table 1 Inclusion and exclusion criteria

From: The efficacy and safety of esketamine in the treatment of major depressive disorder with suicidal ideation: study protocol for a randomized controlled trial

Subject eligibility

Inclusion criteria

1. Aged 13–65 years male and female inpatients;

2. Met the criteria for MDD according to the DSM-5 without psychotic features;

3. Measured by the 17-item Hamilton Depression Rating Scale (HAMD-17) total score ≥ 17;

4. Patients with current suicidal ideation for ≥3 months as measured by a clinician-rated Columbia suicide severity rating scale (C-SSRS) ideation score ≥ 1 and a self-report Beck Scale for Suicide Ideation (SSI) item 4 or 5 score ≥ 2;

5. Subjects with primary school education or above;

6. The subjects who understand the content of the study are willing to join the study and sign the written informed consent.

Exclusion

criteria

1. Patients with other mental disorders diagnosed by DSM-5, including schizophrenia, bipolar disorder, substance related disorder and addiction disorder (except anxiety disorder);

2. Patients with psychotic symptoms in recent 3 months who scored more than 1 in any of the positive symptom items of BPRS (hallucination, exaggeration, suspicion and unusual thinking content);

3. Patients with high suicide risk: had suicidal behavior (defined as self-injuring behavior with intention to die) in the past six months;

4. Patients with history of nervous system diseases such as epilepsy and dementia, or patients with clinically significant and uncontrolled cardiovascular, kidney, liver, gastrointestinal, blood, immune, endocrine, pulmonary diseases or narrow angle glaucoma (judged according to history, physical examination or auxiliary examination);

5. Patients with allergic reaction to ketamine;

6. Patients with positive urine toxicology screening at screening or baseline;

7. Subjects with positive serum / urine pregnancy test or breast-feeding at the time of screening, or planned to be pregnant during the study.

  1. Abbreviations: MDD: major depressive disorder; DSM-5: Diagnostic and Statistical Manual of Mental Disorders