Major depressive disorder (MDD)
Conditions
Interventions
Product Name: [11C]AZ10419369
Pharmaceutical Form: Solution for injection
Product Name: Escitalopram
Pharmaceutical Form: Tablet
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • age 20-80 years • ongoing major depressive episode according to M.I.N.I. interview • healthy, apart from MDD, according to MRI, clinical interview, physical examination, blood tests (Hb, ASAT, ALAT, GT, Na, K, creatinine, calcium, albumin, TSH, glucose). • MADRS>20 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • ongoing pharmacological treatment (wash out-time one month, drugs not used for MDD treatment and without serotonergic effect may be allowed at the discretion of the PI) • bipolar disorder • psychotic syndrome • alcohol/drug dependence • organic central nervous system disorder • patient who is not suitable for MRI (claustrophobia, MRI incompatible metal implants) • pregnancy. • Allergy or hypersensitivity to escitalopram • Ongoing treatment with any medication that is known to prolong the QT interval • Ongoing treatment with any monoamine oxidase inhibitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a clinical study of the downstream mechanism of action of SSRI treatment for MDD. Primary research questions (outcomes): • Does SSRI for MDD reduce serotonin 1B (5-HT1B) receptor binding in the raphe nuclei and increase 5-HT1B receptor binding in serotonin projection areas? • Is this putative change in 5-HT1B receptor binding related to change in MDD symptom rating scores or side effects? ; Secondary Objective: Secondary research questions: • Does SSRI for MDD alter p11 concentration in leucocytes in peripheral blood? • Does a potential change in p11 concentration correlate with 5-HT1B receptor binding in relevant brain regions? • Does change in p11 correlate with change in MDD symptom rating scores? • Is brain activity to fearful versus happy faces reduced in MDD patients who are to respond to SSRI treatment? • Is reward reversal learning impaired in MDD patients? Do the test scores correlate with 5-HT1B receptor binding or brain activity in the striatum? • Is a change in brain activity related to change in 5-HT1B receptor binding or blood p11? • Does a change in brain activity correlate with change in MDD symptom rating scores? • Is the physical activity pattern changed after SSRI? Is any such change related to 5-HT1B receptor binding, brain activity, p11 leucocyte concentration or MDD treatment response? ;Primary end point(s): The primary endpoint is significant change in brain 5-HT1B receptor binding after SSRI treatment for MDD in relation to treatment effect. Based on the previous literature we hypothesize that 5-HT1B receptor binding will be reduced in the raphe nuclei and increased in serotonin projection areas after SSRI. We plan to examine 20 patients, in ac | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated after three weeks of SSRI treatment. Antidepressant effect will be evaluated after six weeks´escitalopram treatment.; Secondary end point(s): • Change in p11 concentration in leucocytes in peripheral blood after escitalopram treatment • Brain activity to fearful versus happy faces in relation to escitalopram treatment response • Physical activity pattern before treatment in relation to escitalopram treatment response • Correlation between potential change in p11 concentration and 5-HT1B receptor binding in relevant brain regions • Correlation between change in p11 and change in MDD symptom rating scores? • Is reward reversal learning impaired in MDD patients? Do the test scores correlate with 5-HT1B receptor binding or brain activity in the striatum? • Is a change in brain activity related to change in 5-HT1B receptor binding or blood p11? • Does a change in brain activity correlate with change in MDD symptom rating scores? • Is the physical activity pattern changed after SSRI? Is any such change related to 5-HT1B receptor binding, brain activity, p11 leucocyte concentration or MDD treatment response? • Change in neuromelanin accumulation index with escitalopram treatment • Changes in cognitive test performance after escitalopram treatment | — |
Countries
Sweden
Contacts
Public ContactClinical Trials Information
Karolinska Institutet PET centre
Outcome results
None listed