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NMDA Modulation in Antidepressant Nonresponders With Major Depressive Disorder

Phase 2
Recruiting
Conditions
Major Depressive Disorder
Registration Number
NCT05136755
Lead Sponsor
China Medical University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Inclusion Criteria:<br><br> - Have a DSM-5 (American Psychiatric Association) diagnosis of MDD<br><br> - Have failed to respond to at least one antidepressant with adequate dosage and<br> treatment duration<br><br> - Their original treatments should have been unchanged for at least 8 weeks. Some<br> treatment-resistant patients (that is, having failed to respond to at least two<br> different classes of antidepressants) who have started to refuse any antidepressant<br> by themselves due to previous failure experience are also allowed, if they have<br> already been antidepressant-free for at least 2 weeks<br><br> - 17-item Hamilton Rating Scale for Depression total score = 18<br><br> - Agree to participate in the study and provide informed consent<br><br>Exclusion Criteria:<br><br> - Current substance abuse or history of substance dependence in the past 6 months<br><br> - History of epilepsy, head trauma, stroke or other serious medical or neurological<br> illness which may interfere with the study<br><br> - Bipolar disorder, schizophrenia or other psychotic disorder<br><br> - Moderate-severe suicidal risks<br><br> - Severe cognitive impairment<br><br> - Initiating or stopping formal psychotherapy within six weeks prior to enrollment<br><br> - A history of previously received electroconvulsive therapy<br><br> - Inability to follow protocol

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in Hamilton Rating Scale for Depression;Change in Global Assessment of Functioning
Secondary Outcome Measures
NameTimeMethod
Change Change in Perceived Stress Scalein Perceived Stress Scale;Visual Analogue Scale for pain;Clinical Global Impression;Quality of life (SF-36);Visual Continuous Performance Test;Wisconsin Card Sorting Test;Logical Memory Test of the Wechsler Memory Scale;Digit Span;Spatial Span;Category Fluency;Trail Marking A;WAIS-III Digit Symbol-Coding;Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0
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