RELATE-TRD

• Conditions: Major Depressive Disorder; MedDRA version: 16.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-001818-14-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-13
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients:
- Male or female, age: 20 - 60 years
- DSM-IV diagnosis of MDD (ascertained by structured interview for DSM-IV (SCID))
- Hamilton Depression Rating Scale (HDRS17)>18
- Without or with resistance to previous antidepressant treatment; described as Group I, non-TRD [who used <=1 antidepressant for the current MDD-episode and are currently drug-free] and Group II TRD [who were nonresponsive to >=2 antidepressants (SSRIs and/or SNRIs) during the current MDD-episode].

Controls:
- Male or female, age: 20 - 60 years
- No DSM-IV diagnosis/abuse/dependence (SCID)
- Inventory for Depressive Symptomatology (IDS-SR) <=14
- Controls will be matched with participating patients on age (+/-3 years), sex and estimated intelligence with the Dutch adult reading test (DART).
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 165
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients:
- Psychotic or Bipolar depression
- Comorbid current (primary) anxiety disorder
- Comorbid current abuse/dependence of alcohol, cannabis, cocaine, amphetamine
- Neurologic or auto-immune disease, hypothyroidism
- Contra-indications for escitalopram or nortriptyline like earlier non-response (in the current episode)
- Contra-indications for fMRI-scanning (metal objects in the body, claustrophobia)

Controls:
- First degree family history of psychiatric illnesses
- Contra-indications for fMRI-scanning
- Neurologic or auto-immune diseases, hypo-/hyperthyroidism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified