RELATE and PREDICT TRD.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27079

Enrollment

105

Registered

2013-04-21

Start date

2013-06-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Major Depressive Disorder

Interventions

1. Escitalopram 5 mg capsules orally dosages adjusted based on blood-levels

2. Nortriptyline 35 mg capsules orally dosages adjusted based on blood-levels

3. Placebo capsules orally dosages adjusted based on fake blood-levels. All interventions will be given for a duration of 8 weeks.

Eligibility

Inclusion criteria

Inclusion criteria: Patients: 1. Male or female, age: 20 - 60 years; 2. DSM-IV diagnosis of MDD (ascertained by structured interview for DSM-IV (SCID)); 3. Hamilton Depression Rating Scale (HDRS17)>18; 4. 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: 1. Male or female, age: 20 - 60 years; 2. No DSM-IV diagnosis/abuse/dependence (SCID); 3. Inventory for Depressive Symptomatology (IDS-SR) <=14; 4. Controls will be matched with participating patients on age (<=3 years), sex and estimated intelligence with the Dutch adult reading test (DART).

Exclusion criteria

Exclusion criteria: Patients: 1. Psychotic or Bipolar depression; 2. Comorbid current (primary) anxiety disorder; 3. Comorbid current abuse/dependence of alcohol, cannabis, cocaine, amphetamine; 4. Neurologic or auto-immune disease, hypothyroidism; 5. Contra-indications for escitalopram or nortriptyline like earlier non-response (in the current episode); 6. Contra-indications for fMRI-scanning (metal objects in the body, claustrophobia). Controls: 1. First degree family history of psychiatric illnesses; 2. Contra-indications for fMRI-scanning; 3. Neurologic or auto-immune diseases, hypo-/hyperthyroidism.

Design outcomes

Primary

Measure	Time frame
Clinical: 1. Decrease in HDRS17-score (continuous scores); 2. Response and remission (defined as >=50% decrease in HDRS17 and a HDRS17=20% decrease in HDRS. Neuroimaging: 1. Pavlovian learning paradigm: BOLD response of prediction errors in VTA/ventral striatum/habenula; 2. PET: amphetamine challenged decrease in [11C]Raclopride binding in the striatum.	—

Secondary

Measure	Time frame
Clinical: 1. Decreases in IDS-SR30; 2. Early improvement (>=20% decrease); 3. Response (>=50% decrease) and remission (IDS-SR30=75% of the facial expressions of emotion for four consecutive intensities); 3. Emotional Categorization: the percentage correct responses and response times to self-referent items, stratified for positive/negative adjectives.	—

Contacts

Public ContactH.G. Ruhe

Academic Medical Center (AMC), Program for Mood Disorders, Department of Psychiatry, P.O. Box 22660

H.G.Ruhe@AMC.UvA.NL+31 (0)20 5662088

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)