Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatments escitalopram, aripiprazole
Phase phase 3
Sponsor University Health Network, Toronto
Collaborator University of Toronto
Start date March 2013
End date August 2018
Trial size 211 participants
Trial identifier NCT01655706, 11-0917-A

Summary

This study is a pilot to assess feasibility of the protocol in patients and controls across six participating sites. The goal is to identify biological markers (biomarkers)that can be measured at baseline or early in treatment to predict treatment outcome in individual patients with Major Depressive Disorder (MDD). Biomarkers of interest will be clinical (using interview and self-report measures), molecular (from blood samples) and neurobiological (using neuroimaging and EEG).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model factorial assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
Patients are on escitalopram for 8 weeks. At Week 8, patients will be assessed as 'responders' or 'non-responders'. 'Responders' will continue on escitalopram until study endpoint.
escitalopram Cipralex
Patients will be given escitalopram for the first 8 weeks of the trial. At week 8, patients who are assessed as 'responders' will continue on escitalopram until study endpoint.
(Active Comparator)
At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.
escitalopram Cipralex
Patients will be given escitalopram for the first 8 weeks of the trial. At week 8, patients who are assessed as 'responders' will continue on escitalopram until study endpoint.
aripiprazole Abilify
At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.

Primary Outcomes

Measure
Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline
time frame: Week 8, Week 16

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

For Depressed patients: Inclusion Criteria: - Outpatients who are 18-60 years of age - Meet DSM-IV-TR criteria for Major Depressive Episode in Major Depressive Disorder by the MINI - Episode duration ≥ 3 months - Free of psychotropic medications for at least 5 half-lives (i.e. 1 week for most antidepressants, 5 weeks for fluoxetine) before baseline Visit 1 - MADRS ≥ 24 - Fluency in English, sufficient to complete the interviews and self-report questionnaires Exclusion Criteria: - Any Axis I diagnosis other than MDD that is considered the primary diagnosis - Bipolar I or Bipolar II diagnosis - Presence of a significant Axis II diagnosis (borderline, antisocial) - High suicidal risk, defined by clinician judgment - Substance dependence/abuse in the past 6 months - Presence of significant neurological disorders, head trauma or other unstable medical conditions - Pregnant or breastfeeding - Failure of 3 or more adequate pharmacologic interventions (as determined by the Antidepressant Treatment History Form) - Started psychological treatment within the past 3 months with the intent of continuing treatment - Patients who have previously failed escitalopram or showed intolerance to escitalopram and patients at risk for hypomanic switch (i.e. with a history of antidepressant hypomania) Inclusion criteria for Healthy Controls: - 18 to 60 years of age - No history of Axis I or Axis II disorders, as determined by the MINI. - Fluency in English, sufficient to complete the interviews and self-report questionnaires.

Additional Information

Official title Integrated Biological Markers for the Prediction of Treatment Response in Depression
Principal investigator Sidney Kennedy, MD
Description This is a study to collect clinical and biomarker data which will be used to build models to predict treatment response. This is not a study to evaluate efficacy of medications, as medications in this study have been approved by Health Canada and are widely used for the treatment of MDD. This is an open label study involving MDD patients and healthy controls.Patients with a diagnosis of MDD and a current major depressive episode (MDE) will receive open-label standard of care treatment with escitalopram (10-20mg). Healthy controls will not receive medication; however, they will go through clinical assessments, blood collection and neuroimaging procedures. At week 8, patients will be assessed for medication response (response is defined as ≥ 50% reduction in MADRS scores from baseline). Responders will continue medication at their effective dose until study endpoint while non-responders will receive open label add-on treatment with aripiprazole (2-10mg). There are approximately 7 clinic visits over a 16 week period during which patients and healthy controls will undergo clinician administered scales and self reports, provide blood and urine samples (which will undergo proteomic and genomic analyses) as well as neuroimaging (fMRI and EEG). At the end of the study, mathematical modeling methods will be used to integrate the data from the various modalities to see which features best predict treatment outcome.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.