Depression
Conditions
Interventions
The protocol strongly encourages all patients to receive sertraline 100 mg/d for 12 weeks using a flexible dose schedule to maximize the chances of obtaining a remission, except for those with clear i
20% reduction in baseline symptom severity as measured by the QIDS-SR16 is found at week 4, the minimum of the effective range (50mg/d) will be titrated (assuming tolerable side effects) to the maximu
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Fulfill criteria for major depressive disorder, as defined by DSM-IV criteria without psychotic features, as determined by clinical assessment and confirmed by the SCID at screening (t1). 2.Aged 20-65 years at t1. 3.Have a GRID-HAMD17 total score 16 at t1 and baseline (t2). 4.The major depressive disorder is the primary diagnosis for the treatment and treating physician has judged sertraline to be appropriate for prescribing. 5.Have an education level and a degree of understanding such that the patient can communicate with the study personnel. 6.Patients must be competent and able to give their own informed consent.
Exclusion criteria
Exclusion criteria: 1.Have had any additional ongoing DSM-IV Axis I condition other than major depressive disorder that is considered as the primary diagnosis within 1 year of t1. 2.Have a current or lifetime diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder at t1. 3.Have a history of substance abuse/dependence within 1 year of t1, not including caffeine and nicotine. 4.Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with the study protocol. 5.Have an evidence of being resistant to sertraline 100 mg/d (maximum dose of the effective range) for at least 6 weeks during this current depressive episode. 6.Women who are currently pregnant or breastfeeding. 7.Patients who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others. 8.Have a serious or unstable medical illness, including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic, renal disease, or clinically significant laboratory or ECG abnormality. 9.Have a history of traumatic head injury or organic brain syndrome such as stroke.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline concentrations of oxygenated hemogloblin [oxy-Hb] during VFT (letter-based word retrieval) and EJT measured by NIRS will be compared between treatment responders and non-responders. Responders will be defined as those who score 50% or greater reduction on baseline GRID-HAMD17 score at the week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes between baseline and the 12 week concentrations of oxy-Hb during VFT and EJT measured by NIRS will be compared between treatment responders and non-responders. 2.Severity of objective depression as measured by GRID HAMD17 and severity of subjective depression as measured by BDI-2. 3.Remission rate at week 12 (Remission will be defined as 7 or less on GRID-HAMD17) 4.Level of quality of life as measured by the European Quality of Life Questionnaire Dimensions (EQ-5D). 5.Level of global burden of side-effect as measured by the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) Scale. 6.Safety and tolerability will be measured by serious adverse event reports (SAEs) and premature discontinuation rate at week 12. 7.The 16-item Quick Inventory of Depressive Symptomatology Self-Reported (QIDS-SR16) will be measured during the protocol treatment for monitoring safety and the acquisition of treatment. | — |
Countries
Japan
Contacts
Public ContactYukiko MIYASAKA
Keio University School of Medicine Department of Neuropsychiatry
Outcome results
None listed