Combined molecular and functional brain imaging (PET/MR) to predict treatment response to neuropharmacological treatment

Patient stratification and treatment response prediction in neuropharmacotherapy using PET/MR – Predicting drug efficacy using hybrid PET/MR imaging with pharmacological challenge and multireceptor modeling - Pharmaco-PET/MR to Predict Antidepressant Drug Efficacy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001550-42-AT

Enrollment

195

Registered

2014-05-07

Start date

2014-06-17

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Major depressive disorder

Interventions

Trade Name: Cipralex Pharmaceutical Form: Tablet INN or Proposed INN: ESCITALOPRAM CAS Number: 128196-01-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Trad

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: General health based on medical history, physical examination and structured clinical interview for DSM-IV (SCID) Age 18 to 55 years HAM-D >17 (MDD patients) 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 195 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Any medical, psychiatric or neurological illness (other than MDD) Psychopharmacological treatment within 3 months prior to inclusion (excepting occasional intake of antihistamines and benzodiazepines, given a wash-out of at least one day prior to PET/MR measurements) Current or former substance abuse (excepting nicotine) Pregnancy Any implant or stainless steel graft or any other contraindications for MRI Participation in studies involving radiation exposure in the past 10 years. Body mass index 30

Design outcomes

Primary

Measure	Time frame
Main Objective: To predict antidepressant treatment response from data obtained using hybrid PET/MR with acute pharmacological challenge (to stratify responders from non-responders). ;Secondary Objective: To correlate changes in molecular imaging measures with changes in brain activation and connectivity.;Primary end point(s): 5-HTT binding potential & occupancy, resting-state brain-activity & connectivity, treatment response scores,;Timepoint(s) of evaluation of this end point: 2 scans, interval of 1 week Response/side effects: every 2 weeks during subsequent 12 weeks of treatment	—

Measure

Time frame

Main Objective: To predict antidepressant treatment response from data obtained using hybrid PET/MR with acute pharmacological challenge (to stratify responders from non-responders). ;Secondary Objective: To correlate changes in molecular imaging measures with changes in brain activation and connectivity.;Primary end point(s): 5-HTT binding potential & occupancy, resting-state brain-activity & connectivity, treatment response scores,;Timepoint(s) of evaluation of this end point: 2 scans, interval of 1 week Response/side effects: every 2 weeks during subsequent 12 weeks of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): brain structure, psychological scores, side effects profiles;Timepoint(s) of evaluation of this end point: Psychological scores:at screening visit Side effects: after scans, every 2 weeks during 12 weeks of treatment	—

Countries

Austria

Contacts

Public ContactUniversitätsklinik für Psychiatrie

Medizinische Universität Wien

neuroimaging@meduniwien.ac.at004314040038250

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026