Major Depressive DisorderPhase 4NCT02711215
Patient Stratification and Treatment Response Prediction in Neuropharmacotherapy Using Hybrid Positron Emmission Tomography/Magnetic Resconance Imaging (PET/MR)
A Phase 4 study testing PET/MR [11C]DASB, Citalopram and Escitalopram (Mirtazapine/Duloxetine/Venlafaxine) in people with Major Depressive Disorder, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- PET/MR [11C]DASB, Citalopram and Escitalopram (Mirtazapine/Duloxetine/Venlafaxine)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- May 2015to Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, 1090
About this study
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:
Read more
- To predict antidepressant treatment response from data obtained using hybrid PET/MR with acute pharmacological challenge.
- To discriminate healthy from depressed subjects using this paradigm.
- 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.
Design: Randomized, double-blind, placebo-controlled, cross-over mono-center study.
Materials and methods:
40 major depressed (MDD) and 40 healthy subjects will undergo 2 PET/MR scans on a 3T SIEMENS mMR Biograph scanner: 1. challenge with citalopram 8mg 2. placebo (saline). After structural imaging, functional MRI will be continuously acquired. [11C]DASB will be applied using a bolus + constant infusion paradigm to probe 5-HTT binding potentials and monitor 5-HTT occupancy with drug challenge, applied after 70min, in a single session. Scanning will be terminated 80min after challenge. MDD patients will receive subsequent escitalopram treatment with repeated evaluation of response for 3 months.
- Conditions
- Major Depressive Disorder
- Being tested
- PET/MR [11C]DASB, Citalopram, Escitalopram (Mirtazapine/Duloxetine/Venlafaxine), Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MR [11C]DASBDiagnostic test
Also called Hybrid imaging, Molecular imaging, SERT binding potential
2 PET/MR scans will be performed (placebo/citalopram - double-blind randomized cross-over)
CitalopramDrug
Also called Seropram
8mg citalopram or placebo (saline) will be applied during PET/MR measurements in a double-blind randomized cross-over design
Escitalopram (Mirtazapine/Duloxetine/Venlafaxine)Drug
Also called Cipralex
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
PlaceboDrug
Also called Saline, NaCL
8mg citalopram or placebo (saline) will be applied during PET/MR measurements in a double-blind randomized cross-over design
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale (HDRS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMay 2015
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Lanzenberger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711215
- Sponsor's protocol ID
- 1.6_20180316
- Status last verified
- Aug 2019
- First submitted
- 14 Mar 2016
- Last updated
- 3 Sep 2019
- Results posted
- No
Publications
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.
PubMed 40550277Seiger 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.
PubMed 33667309
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Stratification and Treatment Response Prediction in Neuropharmacotherapy Using Hybrid Positron Emmission Tomography/Magnetic Resconance Imaging (PET/MR)
- ClinicalTrials.gov ID
- NCT02711215
- Acronym / sponsor ID
- 1.6_20180316
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To predict antidepressant treatment response from data obtained using hybrid PET/MR with acute pharmacological challenge.
- To discriminate healthy from depressed subjects using this paradigm.
- 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.
Design: Randomized, double-blind, placebo-controlled, cross-over mono-center study.
Materials and methods:
40 major depressed (MDD) and 40 healthy subjects will undergo 2 PET/MR scans on a 3T SIEMENS mMR Biograph scanner: 1. challenge with citalopram 8mg 2. placebo (saline). After structural imaging, functional MRI will be continuously acquired. [11C]DASB will be applied using a bolus + constant infusion paradigm to probe 5-HTT binding potentials and monitor 5-HTT occupancy with drug challenge, applied after 70min, in a single session. Scanning will be terminated 80min after challenge. MDD patients will receive subsequent escitalopram treatment with repeated evaluation of response for 3 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MR [11C]DASBAlso: Hybrid imaging, Molecular imaging, SERT binding potential2 PET/MR scans will be performed (placebo/citalopram - double-blind randomized cross-over) | Diagnostic test | – |
| CitalopramAlso: Seropram8mg citalopram or placebo (saline) will be applied during PET/MR measurements in a double-blind randomized cross-over design | Drug | – |
| Escitalopram (Mirtazapine/Duloxetine/Venlafaxine)Also: CipralexAfter 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 | Drug | – |
| PlaceboAlso: Saline, NaCL8mg citalopram or placebo (saline) will be applied during PET/MR measurements in a double-blind randomized cross-over design | Drug | – |
Primary outcome
Hamilton Depression Scale (HDRS)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Derived from this study: PubMed 40550277Zadka 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.
- Derived from this study: PubMed 33667309Seiger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PET/MR [11C]DASB, Citalopram and Escitalopram (Mirtazapine/Duloxetine/Venlafaxine) in people with Major Depressive Disorder, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale (HDRS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02711215, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.