Depression - Major Depressive Disorder
Conditions
Brief summary
The study aims to assess whether providing Clinical Decision Support Software (CDSS) information improves the pharmacological response in patients with depression. The CDSS integrates genomic, clinical, and blood biomarker data to assist psychiatrists in selecting the most appropriate treatment for each patient. A total of 72 patients diagnosed with Major Depressive Disorder were recruited. Participants were male and female adults aged 18 to 65 years, all presenting with moderate to severe symptomatology as assessed by the HAM-D-17 scale. Enrolled patients were randomized into two groups: * TAU group (Treatment as Usual) (+): patients received standard clinical care. * CDSS group: psychiatrists received and could incorporate CDSS-generated information when making treatment decisions. (+) The TAU group received CDSS information at the 12-week follow-up. All patients underwent blood collection at baseline (for blood-based and genomic biomarkers) and completed clinical evaluations at baseline, and at 8, 12, and 24 weeks of follow-up.
Interventions
None listed
Sponsors
Neomente SAS
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Being male or female, aged 18-65. 2. Having a current DSM-5 diagnosis of non-psychotic Major Depressive Disorder confirmed by SCID. 3. Having moderate to severe depressive symptoms as measured by the HAM-D-17. 4. Being indicated for pharmacotherapy for Major Depressive Disorder. 5. Providing written informed consent (signed and dated). \-
Exclusion criteria
1. Having a current or past diagnosis of bipolar disorder or psychotic disorders. 2. Having a moderate to severe substance use disorder within the past six months. 3. Having active suicidal ideation. 4. Having a neurocognitive disorder. 5. Having an unstable or decompensated medical illness likely to confound study outcomes. 6. Being pregnant or lactating. 7. Having known contraindications to the indicated antidepressant classes. 8. Being unable to provide informed consent. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to week 8 in depressive symptoms assessed by HAM-D17 | Changes from baseline to week 8 | To evaluate improvement in depressive symptoms after 8 weeks of treatment in the TAU and CDSS groups, assessed by blinded evaluators using the HAM-D17. Change from baseline in HAM-D 17 total score at Week 8 was reported. The HAM-D 17 is a 17-item scale designed to measure the severity of depressive symptoms in participants. Each item reflects a core symptom of major depression. Items are rated on either a 3-point or 5-point scale, with higher scores indicating greater severity. The total score is the sum of all 17 item scores and ranges from 0 to 52, where higher scores indicate greater overall depressive symptom severity. A negative change in score indicates improvement. Participant meets response criteria if there is at least a 50% reduction in the HAM-D17 total score from baseline to the last observation carried forward (LOCF) endpoint visit. A participant meets remission criteria if the HAMD-17 total score is less than or equal to 7 at the LOCF endpoint visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale-17 items (HAMD-17 | Changes from baseline to week 8 and week 12 | The HAM-D 17 is a 17-item scale. Response is at least a 50% reduction in the 17-item HAM-D17 total score from baseline to the last observation carried forward (LOCF) endpoint visit. Remission is achieved when total score is less than or equal to 7 at the LOCF endpoint visit. |
| Change in self-administered scale: Patient Health Questionnaire-9 (PHQ-9 | Changes from baseline to week 8 and week 12 | PHQ-9 is a 9 item scale that ranges from 0 to 27 where higher scores indicate higher severity. Response is at least a 50% reduction in the total score from baseline to the LOCF endpoint visit. Remission is achieved when the total score is less than or equal to 4 at the LOCF endpoint visit. |
Countries
Argentina
Outcome results
None listed