Psychopharmacotherapy for Depressive Patients
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorChonnam National University Hospital
About this trial
The primary purpose of this study is to compare the short (12 week) and long-term (1-year) efficacy and the tolerability between stepwise psychopharmacotherapy and antidepressant monotherapy for 12 weeks in adult patients with major depressive disorders, stratified by the multimodal serum biomarker scores.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
19 to 65 years
Diagnostic and Statistical Manual of Mental Disorders-IV criteria for major depressive disorder by study psychiatrists
Score≥17 on Hamilton Depression Rating Scale-17
With ability to understand the objective of the study and sign informed consent
Disqualifiers
Current or lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified, or other psychotic disorders
current major depressive disorder with psychotic features
History of organic psychosis, epilepsy, or seizure disorder
Current anorexia nervosa or obsessive compulsive disorder
Trial design
Design model
Parallel
Treatments tested in this trial
stepwise pharmacotherapy
DrugIn the stepwise pharmacotherapy group, treatment strategies (augmentation with antipsychotics (aripiprazole), augmentation with mood stabilizer (lithium),combination (mirtazapine)) will be determined every 3 weeks.
antidepressant monotherapy group
DrugIn the antidepressant monotherapy group, dosage escalation will be determined every 3 weeks.
Treatment groups
400 Participants
are divided into 4 treatment groupsGroup A: Good responder group-stepwise pharmacotherapy groupExperimental treatment 1 intervention
Group B: Good responder group-antidepressant monotherapy groupActive comparator 1 intervention
Group C: Poor responder group-stepwise pharmacotherapy groupExperimental treatment 1 intervention
Group D: Poor responder group-antidepressant monotherapy groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Remission and treatment response status by Hamilton Depression Rating Scale
Remission defined by total scores of Hamilton Depression Rating Scale (0-52; higher score indicates severe symptom) ≤7 and treatment response defined as ≥50% decrease in the baseline total scores of Hamilton Depression Rating Scale after stepwise psychopharmacotherapy or antidepressant monotherapy
Time frame
From baseline to 12 week, 1 yearSecondary outcomes
1
The changes of Hamilton Rating Scale for Depression total score
To measure the change of the severity of depressive symptoms using observer rating scale after stepwise psychopharmacotherapy or antidepressant monotherapy
Time frame
From baseline to 12 week, 1 year2
The changes of Hospital Anxiety and Depression Scale total score, depression subscore, anxiety subscore
The Hospital Anxiety and Depression Scale will be used to measure the change of the severity of depressive symptoms using observer rating scale after stepwise psychopharmacotherapy or antidepressant monotherapy. This scale consists of 14 items with a total score ranging from 0 to 42 and divided into two subscales: 7 items of the anxiety subscale (HADS-A) and 7 items of the depression subscale (HADS-D). Higher scores indicate more severe symptoms.
Time frame
From baseline to 12 week, 1 year3
The changes of Clinical Global Impression-severity and improvement score
The Clinical Global Impression-severity and improvement score is used to measure the change of the global severity and improvement of depressive symptoms after stepwise psychopharmacotherapy or antidepressant monotherapy. This scale is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Higher scores indicate more severe psychopathology.
Time frame
From baseline to 12 week, 1 year4
The changes of Brief Psychiatric Rating Scale suicide item score
Suicidality was evaluated with the suicide-related items on the Brief Psychiatric Rating Scale which assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. Among the 18 items, suicide item that ranges from 1 (not present) to 7 (extremely severe) will be used to measure the change sof suicidality after stepwise psychopharmacotherapy or antidepressant monotherapy.
Time frame
From baseline to 12 week, 1 yearSponsors and contacts
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Source ClinicalTrials.gov