Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)

Study Overview
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Brief Summary
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Major depressive disorder (MDD) is the most common psychiatric disease worldwide with a huge socio-economic impact. Pharmacotherapy represents the first-line treatment choice; however, only about one third of patients respond to the first trial and about 30% are classified as treatment-resistant depression (TRD). TRD is associated with specific clinical features and genetic/gene expression signatures. To date, single sets of markers have shown limited power in response prediction. The aim of this project is the development of a precision medicine algorithm that would help early detection of non-responder patients, who might be more prone to later develop TRD. In this phase of the project a naturalistic cohort of 300 MDD patients will be recruited. The data collected will be used to assess, in real-world conditions, the capability of an innovative algorithm (integrating clinical, omics and gender data of other 300 patients con MDD) to predict the treatment outcomes. This project represents a proof-of-concept study. The obtained results will provide information about the feasibility and usefulness of the proposed approach, with the perspective of designing future clinical trials in which algorithms could be tested as a predictive tool to drive decision making by clinicians, enabling a better prevention and management of MDD resistance.

Official Title
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Toward PrecisiOn Medicine for the Prediction of Treatment Response in Major Depressive Disorder Through Stratification of Combined Clinical And-omics Signatures (PROMPT)

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Antidepressant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A current diagnosis of moderate to severe MDD according to the DSM-IV was confirmed using the SCID-I diagnostic scale Exclusion Criteria: Mental retardation or cognitive disorder A lifetime history of schizophrenic, schizoaffective, or bipolar disorder Substance abuse in the last 3 months Personality disorders, substance abuse, alcohol abuse, obsessive compulsive disorder, post-traumatic stress disorder, as primary diagnosis Comorbidity with eating disorders Substance or alcohol dependence
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Antidepressant|Antidepressant (AD) monotherapy or complex psychopharmacology such as two ADs or AD plus augmentation (second generation antipsychotics, mood stabilizers, lithium, FT3/FT4). Combination with diverse types of ongoing psychotherapy will be accepted, if commenced prior to baseline|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | Symptom improvement as measured by the percent change in the Montgomery-Asberg Depression Rating Scale (MADRS) score | Baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response and remission | Symptom improvement as well as response and remission rates as according to the MADRS | Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks |