International Study to Predict Optimised Treatment - in DepressioniSPOT-D - iSPOT-D
- Conditions
- Patients suffering from major depressive disorder (MDD) as well as healthy control participants. Only patients will receive medication which will be 'treatment as usual'.
- Registration Number
- EUCTR2008-004122-17-NL
- Lead Sponsor
- BRC operations Pty. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2163
Patients:
- Meet DSM-IV criteria for primary diagnosis of MDD
- HAM-D21 score of >16.
Patients and controls
-18-65 years age-range (inclusive)
- Subjects with Dutch fluency.
- Written, informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Presence of suicidal ideations and/or tendencies, bipolar disorder, psychosis or primary eating disorders.
- Pregnancy and women of child bearing potential who are not taking a medically
accepted form of contraception
- Breastfeeding.
-Known contra-indication to the use of Escitalopram, Sertraline or Venlafaxine XR as
defined in the product package insert for each drug
-Use of any antidepressant or CNS drug which can not be washed out prior to
participation.
-Use of any medication which is known to be contraindicated
- Evidence of either hyper or hypo-thyroidism within previous 3 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method