Patient Stratification and Treatment Response Prediction in Neuropharmacotherapy Using Hybrid Positron Emmission Tomography/Magnetic Resconance Imaging (PET/MR)

NCT02711215 | Unknown Phase 4

• 1 other identifier: 1.6_20180316
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Selective serotonin reuptake inhibitors (SSRIs) raise serotonin (5-HT) in the synaptic cleft and are the current first line of pharmacological antidepressive treatment. Yet, there is a missing link between this first molecular step in their mechanism of action and observed clinical improvement. We have determined to establish a framework combining genuine molecular and functional imaging, i.e. hybrid pharmaco-PET/MR imaging, of the human serotonergic system in order to predict antidepressant treatment response. Objectives:

1. 1.To predict antidepressant treatment response from data obtained using hybrid PET/MR with acute pharmacological challenge.
2. 2.To discriminate healthy from depressed subjects using this paradigm.
3. 3.To establish models connecting regional changes in occupancy of serotonin transporters (5-HTT) following citalopram infusion, with changes in brain activation and connectivity of major resting-state hub networks.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Scale (HDRS)

  12 weeks

Interventions

PET/MR [11C]DASB DIAGNOSTIC_TEST

2 PET/MR scans will be performed (placebo/citalopram - double-blind randomized cross-over)

Also known as: Hybrid imaging, Molecular imaging, SERT binding potential

Citalopram DRUG

8mg citalopram or placebo (saline) will be applied during PET/MR measurements in a double-blind randomized cross-over design

Also known as: Seropram

Escitalopram (Mirtazapine/Duloxetine/Venlafaxine) DRUG

After completion of imaging procedures, patients will receive treatment with escitalopram 10-20mg. In case of non-response, after 6 weeks, treatment will be switched to either Mirtazapine, Duloxetine or Venlafaxine

Also known as: Cipralex

Placebo DRUG

8mg citalopram or placebo (saline) will be applied during PET/MR measurements in a double-blind randomized cross-over design

Also known as: Saline, NaCL

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• General health based on medical history, physical examination and structured clinical interview for DSM-IV (SCID)
• HAM-D≥18 (patients)
• Willingness and competence to sign the informed consent form
• Age 18 to 55 years

You may not qualify if:

• Any medical, psychiatric or neurological illness (other than MDD)
• Current or former psychopharmacological treatment
• Current or former substance abuse
• Pregnancy
• Any implant or stainless steel graft or any other contraindications for MRI
• Failure to comply with the study protocol or to follow the instructions of the investigating team
• Participation in studies involving radiation exposure in the past 10 years.
• Body mass index \<17 or \>30

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

• Zadka L, Eggerstorfer B, Buzalewicz I, Vraka C, Rusak A, Godbersen GM, Opalinska A, Unterholzner J, Ulatowska-Jarza A, Philippe C, Haczkiewicz-Lesniak K, Silberbauer LR, Murgas M, Nics L, Hahn A, Hacker M, Gomulkiewicz A, Rujescu D, Podhorska-Okolow M, Lanzenberger R, Gryglewski G. Phenotyping extracellular vesicles and their serotonin transporter cargo in major depressive disorder. J Affect Disord. 2025 Nov 15;389:119740. doi: 10.1016/j.jad.2025.119740. Epub 2025 Jun 21.

  PMID: 40550277 DERIVED

• Seiger R, Gryglewski G, Klobl M, Kautzky A, Godbersen GM, Rischka L, Vanicek T, Hienert M, Unterholzner J, Silberbauer LR, Michenthaler P, Handschuh P, Hahn A, Kasper S, Lanzenberger R. The Influence of Acute SSRI Administration on White Matter Microstructure in Patients Suffering From Major Depressive Disorder and Healthy Controls. Int J Neuropsychopharmacol. 2021 Jul 23;24(7):542-550. doi: 10.1093/ijnp/pyab008.

  PMID: 33667309 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Multimodal Imaging; Molecular Imaging; Citalopram; Escitalopram; Mirtazapine; Dexetimide; Sodium Chloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Molecular Probe Techniques; Investigative Techniques; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Neuroimaging Labs

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 17, 2016
• Study Start: May 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: September 3, 2019

Record last verified: 2019-08

Locations

AU (1)