The overall objectives of the iSPOT-D trial are to use standardised genetic-brain-cognitionprotocols to:1. Identify markers of MDD as a diagnostic group and its subtypes2. Identify markers which change with acute (8 weeks) drug treatment in MDD3.…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
n.v.t.
Background summary
MDD is projected to cause the second greatest global burden of disease by 2020,
highlighting the urgent need for valid predictors of effective treatment
response. Currently, there are no accurate predictors of response to
antidepressants in MDD, and successful treatment relies greatly on 'trial and
error'. The aim of this study is to identify genetic, brain and cognitive
assessment/test results that statistically correlate to and predict a treatment
response (further referred to as 'markers' ) to the three most commonly used
antidepressants (Escitalopram, Sertraline and Venlafaxine XR,) in subjects
diagnosed with major depressive
disorder (MDD).
Study objective
The overall objectives of the iSPOT-D trial are to use standardised
genetic-brain-cognition
protocols to:
1. Identify markers of MDD as a diagnostic group and its subtypes
2. Identify markers which change with acute (8 weeks) drug treatment in MDD
3. Identify predictors of treatment response in MDD, and types of response
4. To determine whether distinct individual characteristics in MDD subjects
predict degree of
response to different treatment with different medications
Secondary questions will also be explored systematically within each of the
above objectives:
1. Whether the markers of MDD and its sub-types also distinguish clusters of
comorbid
conditions in MDD.
2. Whether the extent of change in markers with treatment is associated with
other
subject*s characteristics, such as age and sex.
3. If markers which predict severity and response to treatment, also predict
other aspects
of drug response, such as number of side effects.
Study design
This is an open-label, Randomised (effectiveness) study (ie. comparison of
active treatments)
to identify genetic markers, brain function, brain structure, and psychological
and cognitive
indicators (or a combination of markers) in MDD subjects versus healthy
controls.
Approximately 2,016 subjects with major depressive disorder (MDD) across
multiple
international sites will be randomised to one of three approved and effective
treatment arms:
Treatment A Escitalopram.
Treatment B Sertraline.
Treatment C Venlafaxine XR.
A group of matched healthy controls (n = 672) will also be enrolled. Healthy
control subjects will be matched to enrolled MDD subjects.
Study burden and risks
Time investment for the participant includes:
- screening measures (140 minutes): blood draw, pregnancy test, tox screen,
psychiatric interview
- baseline assessment (200 minutes): a variety of questionnaires,
neuropsychological test battery, neurophysiological test battery
- Clinical monitoring (8 x 10 mintues = 80 minutes): telephone interview,
questionnaires
- Week 8 assessment (350 minutes): blood draw, questionnaires,
neuropsychological test battery, neurophysiological (qEEG) test battery
Participation requires at least two visits to the clinics and 8 telephone
interviews. Participants get paid 280 euro for participation.
Blood draw can be associated with local pain, bruising, occasional
lightheadedness, fainting, and very rarely, infection at the site of the blood
draw.The group of subjects with MDD will receive treatment with one of three
registered medication (treatment as usual). Subjects can experience known
side-effects of medication.
235 Jones Street
Ultimo 2007, NSW
AU
235 Jones Street
Ultimo 2007, NSW
AU
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-004122-17-NL |
| CCMO | NL23574.072.08 |