An Antidepressant Medications from Treatment Initiation for Depressive Disorder with Cognitive Impairment: A Prospective Comparative Study

Not Applicable

• Conditions: Mental and behavioral disorders

• Registration Number: KCT0002173
• Lead Sponsor: Korea University Ansan Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

1)Study participants were recruited from consecutive outpatients, 18-65 years of age, who met the diagnostic criteria of Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for major depressive disorder without psychotic feature.
2)The patients who have a score = 14 on the 17-items of Hamilton Depression Rating Scale (HAMD-17).
3) Patients who complain cognitive decline (subjective cognitive impairment)
4) A new patients at intake who have not been treated by antidepressant (more than 2 weeks), or a patient in ongoing treatment who did not show the treatment response despite taking an enough antidepressant treatment.

- Enough antidepressant treatment is defined as more than 6-weeks treatment. Treatment response is defined as 50+% improvement from baseline to follow-up, or total score < 10 on HAMD-17.

- Enough doses are as follows: Escitalopram 10-20 mg/d, fluoxetine 20-40 mg/d, paroxetine controlled release (CR) 12.5-62.5 mg/d or paroxetine 10-40 mg/d, sertraline 50-150 mg/d, bupropion XL (SR) 150-300 mg/d, mirtazapine 15-45 mg/d, venlafaxine immediate or extended release (IR or ER) 75-225 mg/d, duloxetine 30-60 mg/d, tianeptine 12.5-2 5mg/d.

5) Prior to study entry, patients who provided written informed consent in a protocol approved by institutional review boards.

Exclusion Criteria

Bipolar disorder, Schizophrenia, Schizoaffective disorder, Schizophreniform disorder, Patients who suffered current or lifetime psychotic symptoms, Psychotic depression, Organic mental disorder, Seizure or epilepsy, Current eating disorder, Concurrent obsessive-compulsive disorder, Patients with underlying medical disease that could affect study evaluation. Patients who received electroconvulsive therapy for current depressive episode. Patients who were recommended to be hospitalized (for example, alcohol dependence, drug abuse), Patients who were evaluated as high risk of suicide or self-mutilation, Pregnancy, Breastfeeding.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression (CGI-S, CGI-I);Hamilton Depression Rating Scale-17 (HAMD-17);Montgomery-Asberg Depression Rating Scale (MADRS);Clinically Useful Depression Scale (CUDOS);Global Deterioration Scale (GDS);The British Columbia Cognitive Complaints Inventory (BC-CCI);Perceived Deficits Questionnaire-Depression (PDQ-D)

Secondary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Scale (HAMA);Clinically Useful Anxiety Scale (CUXOS);Global Assessement of Functioning (GAF);Sheehan Disability Scale (SDS);WHO quality of life assessment instrument (WHOQOL-BREF);Adverse effect (SAFTEE-SI);Patient Health Questionnaire-15 (PHQ-15)