Major Depression
Conditions
Interventions
Trade Name: Cipralex® 10 mg - Filmtabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Escitalopram
Other descriptive name: Escitalopram
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Medical University of Vienna, University Department of Psychiatry and Psychotherapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female subjects aged between 18-65 years of age • Depressive patients: DSM-IV diagnosis of MDD following SCID I, HDRS29, MADRS and BDI-II • Satisfactory general health as determined by past medical history, physical examination, vital signs at screening • Vital signs measured after 3 minutes resting in the supine position must be within the following ranges: oral body temperature between 35.0-37.5 °C, systolic blood pressure 90-140 mmHg, diastolic blood pressure 50-90 mm Hg, pulse rate 40-100 bpm • Subjects must weigh 50-100 kg to participate in this study with a BMI within 19-26. • Sufficient visual and auditory performance for neuropsychological testing • Written informed consent will be obtained prior to the start of any study procedures. Therefore, willingness and competence to sign the informed consent form is needed. • Potential patients must be able to communicate well with the investigator and comply with the requirements of the study • Only participants who are legally authorized to give informed consent will be included in the present study. 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 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Depressed patients: Presence of any severe / unstable neurological, somatic or psychiatric comorbidity • Healthy controls: Any psychiatric disease or any severe / unstable neurological or somatic disease • Presence of psychotic symptoms • Acute suicidality • Any contraindication for magnetic resonance or PET imaging • Presence of any metallic implant in the head • History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to one of the study drugs or multiple study drugs (known hypersensitivity to bupropion, escitalopram) • Other clinically significant abnormality on physical, neurological, or laboratory examination or on electrocardiogram (ECG) that, in the opinion of the investigator precludes the patient from the study • Ingestion of antidepressants or other psychotropic agents within the last 6 months Previous escitalopram- or bupropion intake • Antidepressive trials wit DBS, electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or Ketamine • Current smoking, substance abuse including alcohol, drugs of abuse, or any medication in a manner which is indicative of substance-related disorders (e.g. substance dependency) according to DSM-IV • Failure to comply with the study protocol or follow the instructions of the investigators • Positive urine pregnancy test • Known pregnancy or lactation • MRI scan that shows evidence of stroke, infarct, or other space occupying lesion or structural abnormality • History of any other drug or alcohol abuse or misuse • Participation in any clinical investigation within 12 weeks prior to dosing • Evidence from an Allen test of incomplete communication between the radial and ulnar artery, in either hand • Significant radiation exposure (>5 mSv) in the frame of participation in trials within the past 10 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Identifying reward-specific alterations in dopamine synthesis (PET) in the nucleus accumbens (NAcc) in patients with MDD compared to healthy volunteers applying the Monetary Incentive Delay Task - To assess the effect of two different antidepressant agents (escitalopram, bupropion) on reward consumption and reward-specific NAcc dopamine synthesis rates in patients with MDD in a longitudinal design - To assess the relationship between reward-specific NAcc dopamine synthesis and treatment response in MDD;Secondary Objective: - To analyze the relationship between reward-specific dopamine synthesis and fMRI activation across healthy volunteers and patients with MDD - To identify remission rates in MDD patients being treated with either escitalopram OR bupropion in a longitudinal design - To assess the test-retest reliability of quantifying dopamine synthesis rates applying the same PET protocol across healthy controls Magnetic resonance spectroscopy (optional): - Relationship between reward-specific dopamine synthesis and GABA/glutamate in the brain -Baseline differences in brain GABA/glutamate between depressed and healthy subjects - Relationship between clinical outcome after antidepressant therapy with a)escitalopram or b)bupropion and changes in GABA/glutamate in the brain;Primary end point(s): Reward-specific changes of dopamin-synthesis;Timepoint(s) of evaluation of this end point: Data analysis will be performed 42-56 days (+/- 2 days) of study participation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To analyze the relationship between reward-specific dopamine synthesis and fMRI activation across healthy volunteers and patients with MDD - To identify remission rates in MDD patients being treated with either escitalopram OR bupropion in a longitudinal design - Test-retest reliability for the quantification of dopamine synthesis rates in healthy volunteers;Timepoint(s) of evaluation of this end point: Data analysis on the aforementioned secondary end points should be carried out as of day 42 (+/- 2 days) or (behavioral data of depressive patients) as of day 132 (+/- 7 days). | — |
Countries
Austria
Contacts
Public ContactNEUROIMAGING LABS
Medical University of Vienna, University Department of Psychiatry and Psychotherapy
Outcome results
None listed