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International Study for the Prediction of Optimized Treatment - in Depression

International Study for the Prediction of Optimized Treatment - in Depression - iSPOT-D

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON32293
Enrollment
500
Registered
2008-08-04
Start date
2008-12-29
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression major depressive disorder

Interventions

None listed

Sponsors

Brain Resource Company
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
n.v.t.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)