International Study to Predict Optimised Treatment – in Depression

Main objective

There are a range of medications offered to subjects with depression. One of the challenges for the clinician is to identify markers which will provide an objective way to determine the magnitude of improvement that can be expected with a particular treatment for a particular individual. Currently there are no accurate predictors of how patients will respond to antidepressant treatment.

The aim of this study is to provide data which may help take the ‘trial and error’ out of prescribing effective antidepressant medication. Over 52 weeks, patient responses to antidepressant medication will be compared to non-patient control responses using genetic, psychological and physiological measures. It is an open label, randomised trial, where patients will be placed on one of escitalopram, sertraline or venlafaxine.

Main Inclusion Criteria for Patients

• Meets DSM-IV-TR criteria for a primary diagnosis of MDD
• Currently depressed as measured by a HAM-D21 score of  at least 16
• Males or females between 18 and 65 (inclusive)  years of age
• Able to provide informed consent

Main Exclusion Criteria for Patients

• Participants currently now on any of the three antidepressants used in the study- of escitalopram, sertraline, venlafaxine or CNS medication
• Presence of suicidal ideation and/or tendencies, bipolar disorder, psychosis or primary eating disorders
• Pregnancy and/or breastfeeding
• Serious illness including cardiovascular, hepatic, renal, respiratory, haematologic, endocrine and neurologic diseases
• Substance dependence according to ABS criteria
• History of brain trauma

Benefits

The patient’s depression will hopefully improve during the study.  Study participants will receive psychological and physiological testing, the results of which can be provided back to the treating doctor.  The study also aims to further medical knowledge to improve future treatment of depression. Participants will be compensated for their time, inconvenience, and reasonable travel expenses.

Please contact Niharika Anand on 9076 8045  n.anand@alfred.org.au for more information.  An explanatory document is available here.  Participants need to attend the Alfred hospital in Melbourne for the two testing sessions.