Major Depressive Disorder
Conditions
Interventions
None listed
Sponsors
Nomoto Keisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age older than or equal to 18 years, outpatient at a psychiatric department at the time of signing the informed consent form (ICF). 2. Patients with a primary diagnosis of Major Depressive Disorder with single or recurrent episodes without psychotic or mixed features, according to DSM-5 criteria. 3. Patients with CGI-S score more than or equal to 4 at baseline (Visit 1). 4. Patients who are scheduled to initiate treatment with venlafaxine according to the local Japanese label. 5. Patients with written consent and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients who have been previously treated with venlafaxine or desvenlafaxine. 2. Patients who meet the following based on the DSM-5 diagnostic criteria: a. Diagnosis of alcohol or substance use disorders (other than nicotine or caffeine) within 12 months prior to the start of the study. b. Prior or current diagnosis of schizophrenia spectrum or other psychotic disorders. c. Prior or current diagnosis of bipolar or related disorder. 3. Patients with a history of convulsive disease other than single febrile seizures during childhood. 4. Patients with dementia or other neurodegenerative disease that significantly affects cognitive function. 5. Patients with depression due to another medical condition or substances. 6. Patients who are receiving or will receive treatment within 12 weeks with electro convulsive therapy (ECT) or repeated transcranial magnetic stimulation (rTMS). 7. Patients with serious or unstable diseases or conditions, such as severe renal or hepatic dysfunction. 8. Patients judged to be at risk of suicide by the Investigator. 9. Patients currently enrolled or scheduled in another clinical research/trial. 10. Patients who are considered inappropriate by the Investigator to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the MADRS total score from baseline to treatment completion (Week 12) or discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline on the following scales: - MADRS each item score - CGI-S - Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) total score - Generalized Anxiety Disorder 7-item (GAD-7) total score - Sheehan Disability Scale (SDISS) total Score - Total score of 5-level EuroQol-5 Dimension (EQ-5D-5L) scores - Perceived Deficits Questionnaire for Depression 5-item (PDQ-D-5) total score Score at each study visit in treatment period - CGI-I Calculate the rate at each study visit in treatment period - Response rate by CGI-I - Response rate by MADRS - Remission rate by MADRS - Treatment continuation rate - The frequency of anxious distress in Major Depressive Disorder. - The factors associated with anxious distress. - The factors associated with the response by the MADRS. - The factors associated with remission by the MADRS. - The factors associated with treatment continuation. Safety Measures: - AEs during the dosing phase. - AEs/serious adverse events (SAEs) leading to withdrawal. - SAEs leading to death. | — |
Contacts
Public ContactMisa Arata
IQVIA Services Japan G.K.
Outcome results
None listed