Major depressive disorder (MDD) with cognitive impairment
Conditions
Interventions
Control group:No additional neuromodulation intervention
Intervention group:Targeted Memory Reactivation (TMR)-based neuromodulation therapy
Sponsors
Beijing An Ding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 60 years (inclusive), regardless of sex. 2.Outpatients diagnosed with a single or recurrent episode of depressive disorder, as determined by the investigator based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 3.Currently in the remission phase of depression, defined as a total score of <= 12 on the Montgomery–Åsberg Depression Rating Scale (MADRS). 4.Impairment in at least two cognitive domains, indicated by T-scores <40 on the MATRICS Consensus Cognitive Battery (MCCB). 5.Educational attainment of primary school level or above. 6.Willingness to participate in the study, with written informed consent signed by the participant and their guardian or legal representative (if applicable), and the ability to understand and comply with study procedures.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of psychiatric disorders other than depressive disorder as defined by DSM-5, including but not limited to schizophrenia, bipolar disorder, neurodevelopmental disorders, obsessive-compulsive and related disorders, trauma- and stressor-related disorders, dissociative disorders, anorexia nervosa or bulimia nervosa, and personality disorders. 2.Depression secondary to other physical (somatic) diseases. 3.History of epileptic seizures, excluding febrile convulsions during childhood. 4.Receipt of systematic physical treatments for depression within 3 months prior to enrollment, including modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), light therapy, or systematic psychotherapy. 5.Clear suicidal attempts or behaviors within the past year, or a score >= 3 on item 10 (suicidal thoughts) of the Montgomery–Åsberg Depression Rating Scale (MADRS). 6.Presence or history of malignant tumors, or severe and unstable physical illnesses, including cardiovascular, hepatic, renal, hematological, or endocrine diseases. 7.Pregnant or breastfeeding women; individuals (male or female) who are unable or unwilling to use effective contraception, or who plan to conceive from the time of informed consent signing until 30 days after study completion. 8.Clinically significant impairment of vision (including uncorrected refractive errors), or clinically significant hearing or olfactory dysfunction. 9.Inability to comply with treatment procedures, or any other condition that, in the opinion of the investigator, makes the participant unsuitable for the study. 10.Known allergy to aromatherapy agents or similar substances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the MCCB composite score from baseline to week 4; | — |
Secondary
| Measure | Time frame |
|---|---|
| Resting-state EEG power spectral density at the end of the 4-week intervention;Resting-state EEG power spectral density at the end of the 6-week intervention;Change in HAMA score from baseline to week 6;Changes in resting-state and task-based neuroimaging data at week 6;Sleep EEG power spectral density at the end of the 4-week intervention;Sleep EEG power spectral density at the end of the 6-week intervention;Changes in domain-specific scores of the MATRICS Consensus Cognitive Battery (MCCB) from baseline to week 4;Changes in domain-specific scores of the MATRICS Consensus Cognitive Battery (MCCB) from baseline to week 6;Change in HAMA score from baseline to week 4;Change in Clinical Global Impression (CGI) score from baseline to week 6;Change in 17-item Hamilton Depression Rating Scale (HAMD-17) score from baseline to week 4;Changes in resting-state and task-based neuroimaging data from baseline to week 4;Change in 17-item Hamilton Depression Rating Scale (HAMD-17) score from baseline to week 6;Change in Clinical Global Impression (CGI) score from baseline to week 4;Incidence and details of adverse events (AEs) and serious adverse events (SAEs); | — |
Countries
China
Contacts
Public ContactHongli Wang
Beijing An Ding Hospital, Capital Medical University
Outcome results
None listed