RELATE and PREDICT TRD;A pharmacological and neuroimaging study investigating neurobiological effects of Selective Serotonin Reuptake Inhibitors and Norepinephrine Reuptake inhibitors on dopaminergic reward-learning signals and prediction of clinical (non-) response in Major Depressive Disorder

Phase 4

Completed

Conditions: Chronic Depression
Treatment Refractory Depression
Treatment Resistant Depression
10027946

Registration Number: NL-OMON38845

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 165

Inclusion Criteria

Patients:
- Male or female, age: 20 - 60 years
- Signed informed consent
- DSM-IV diagnosis of MDD (ascertained by structured interview for DSM-IV (SCID))
- Hamilton Depression Rating Scale (HDRS17)>18
- Group I, non-TRD [who used <=1 antidepressant for the current MDD-episode and are currently drug-free]
- 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
- Signed informed consent
- 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).

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)
For blood-measurements regarding research questions 4.1-4.3
- Use of aspirin and psychopharmaca other than used in study setting
- Alcohol abuse (8 weeks prior to participation: for women >14 consumptions/week, and for men >21 consumptions/week).
- Consumption of bananas and walnuts 48 hours prior to blood withdrawal.;Controls:
- First degree family history of psychiatric illnesses
- Contra-indications for fMRI-scanning (for neuroimaging participants)
- Neurologic or auto-immune diseases, hypo-/hyperthyroidism

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Clinical:<br /><br>- decrease in HDRS-17-score<br /><br>- response and remission (defined as >=50% decrease in HDRS-17 and a<br /><br>HDRS-17<=7, respectively)<br /><br>- early improvement in week 2 will be defined as >=20% decrease in HDRS-17<br /><br><br /><br>Neuroimaging:<br /><br>- Pavlovian learning paradigm: BOLD response of prediction errors in<br /><br>VTA/ventral striatum/habenula<br /><br>- PET: amphetamine challenged decrease in [11C]Raclopride binding in the<br /><br>striatum</p><br>

Secondary Outcome Measures