International Study for the Prediction of Optimized Treatment - in Depressio

Phase 4

Completed

• Conditions: depression; major depressive disorder; 10027946

• Registration Number: NL-OMON32293
• Lead Sponsor: Brain Resource Company

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-05-01
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

meet DSM-IV criteria for primary diagnosis of MDD (patients), HAMD score>16 (patients), age between 18-65, Dutch fluency (patients and healty controls) signed a written informed consent (patients and health controls)

Exclusion Criteria

1) presence of bipolar disorder, psychosis or primary eating disorders (patients) or current or previous diagnosis of MDD or other Axis 1 disorder (healthy controls) 2) pregnancy and women of child bearing potential who are not taking a medically accepted form of contraception and are at risk of becoming pregnant during the study, 3) breastfeeding, 4) presence of contra-indication of usage of Escitalopram, Sertraline or Venlafaxine XR (patients) 5) usage of any antidepressant or CNS drug which can not be washed out prior to participation 6) use of any medication which is known to be contraindicated with Escitalopram, Sertraline, or Venlafaxine XR 7)evidence of either hyper or hypo-thyroidism within previous 3 months, 8) known medical condition, disease or neurological disorder which might, in the opinion of the investigator, interfere with the assessments to be made in the study or put subjects at increased risk when exposed to optimal doses of the drug treatment, 9) personal history of physical brain injury or blow to the head that resulted in loss of consciousness of greater than five minutes, 10) recent/current substance dependence in accordance with current ABS criteria in the past 6 months, 11) participation in an investigational study within four months of the baseline visit in which subjects have received an experimental drug/device that could affect the primary end points of this study, 12)subjects who, in the opininon of the investigator, have a severe impediment to vision, hearing and/or hand movement, which is likely to interfere wiht their ability to complete the testing batteries, 13) subjects who, in the opininon of the investigator, are unable and/or unlikely to comprehend and follow the study procedures and instructions.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In order to answers the studys' objectives, profiles of genetic, psychological,<br /><br>cognitive and<br /><br>brain markers will be used (for details see protocol page 21 and further)<br /><br>- Psychological test markers: number of stressful events<br /><br>- Cognitive test markers: Scores are performance scores in each test: including<br /><br>accuracy and reaction time. Factor scores will also be derived for the<br /><br>composite domains.<br /><br>- Electrical Brain Function markers: EEG Power in the four frequency bands,<br /><br>delta, theta, alpha and beta, EEG Asymmetry,<br /><br>EEG synchrony, ERP amplitudes and latencies for the components of key interest<br /><br>in a variety of tasks.<br /><br>- Heart rate and Heart rate variability will be quantified<br /><br>- Skin Conductance<br /><br>- EMG responses to each startle/prepulse stimulus<br /><br>- Genetic markers (a variety of targets see protocol page 27)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.v.t.</p><br>