Major Depressive Disorder (MDD)Phase 4MAN-BIOPSYNCT01477203
Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders
A Phase 4 study testing Escitalopram in people with Major Depressive Disorder (MDD) and Anxiety Disorder, run by Medical University of Vienna at 1 site in Austria.
Trial summary
MAN-BIOPSY pursues the concrete research question whether novel biological and psycho-physiological clusters or categories can be defined to improve treatment and minimize side effects in psychiatry, based on a synopsis of physiological, behavioural, genetic and endocrinological parameters. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD), Anxiety Disorder
- What is being tested?
- Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2011to Sep 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) by a structured clinical interview (SCID)
- aged 18 to 50 years
- drug-free within the last three months prior inclusion
- willingness and competence to sign the informed consent form
- a previous DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) but no symptoms at present, determined by SCID
- aged 18-50 years
Show all 11Show fewer
- drug-free within the last three months prior inclusion
- willingness and competence to sign the informed consent form
- willingness and competence to sign the informed consent form
- aged 18-50 years
- drug-free
Who cannot join
- concomitant major internal or neurological illness
- concomitant psychiatric disorders (except depression and anxiety for patients, excluding PTSD, claustrophobia and bipolar disorder)
- ingestion of any antipsychotic, antidepressant, or anti-anxiety agent within the last three months prior to the screening visit
- current substance abuse
- failure to comply with the study protocol or to follow the instructions of the investigating team
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department for Psychiatrie and Psychotherapie
Vienna, State of Vienna, 1090
About this study
MAN-BIOPSY pursues the concrete research question whether novel biological and psycho-physiological clusters or categories can be defined to improve treatment and minimize side effects in psychiatry, based on a synopsis of physiological, behavioural, genetic and endocrinological parameters. One major aspect of our research approach is its focuses on the identification of dysfunctions in fundamental information processing mechanisms and neurocomputational mechanisms, and is not restricted to symptom-oriented tasks.
The main objectives of MAN-BIOPSY are therefore
- to identify biological and psycho-physiological parameters for major depressive disorders and anxiety disorders, and
- to identify predictive markers for treatment response and type/severity of side effects for these disorders.
- Conditions
- Major Depressive Disorder (MDD), Anxiety Disorder
- Being tested
- Escitalopram
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
2-4 weeks, 5-10mg, max 20mg
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Active comparator | 50 Major Depressive Disorder Patients and 50 Anxiety Disorder Patients will receive Escitalopram as medication Receives: Drug: Escitalopram |
| Remitted Patients | No intervention | Not described |
| Healthy Controls | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSRI induced changes in BOLD (blood oxygen level dependent) response over time
Measured: 4 vears
SSRI induced changes in ERPs (event-related potentials) over time
Measured: 4 years
Secondary outcomes (1)
biochemical data
these include steroid hormone levels, vitamins, etc.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
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
- NCT01477203
- Sponsor's protocol ID
- FA103FC001
- Other IDs
- 2011-004860-31
- Acronym
- MAN-BIOPSY
- Status last verified
- Sep 2016
- First submitted
- 15 Nov 2011
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT01477203
- Acronym / sponsor ID
- MAN-BIOPSY / FA103FC001
- Conditions
- Major Depressive Disorder (MDD), Anxiety Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Nov 2011 (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.
MAN-BIOPSY pursues the concrete research question whether novel biological and psycho-physiological clusters or categories can be defined to improve treatment and minimize side effects in psychiatry, based on a synopsis of physiological, behavioural, genetic and endocrinological parameters. One major aspect of our research approach is its focuses on the identification of dysfunctions in fundamental information processing mechanisms and neurocomputational mechanisms, and is not restricted to symptom-oriented tasks.
The main objectives of MAN-BIOPSY are therefore
- to identify biological and psycho-physiological parameters for major depressive disorders and anxiety disorders, and
- to identify predictive markers for treatment response and type/severity of side effects for these disorders.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Active comparator | Drug: Escitalopram50 Major Depressive Disorder Patients and 50 Anxiety Disorder Patients will receive Escitalopram as medication |
| Remitted Patients | No intervention | – |
| Healthy Controls | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) by a structured clinical interview (SCID)
- aged 18 to 50 years
- drug-free within the last three months prior inclusion
- willingness and competence to sign the informed consent form
- a previous DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) but no symptoms at present, determined by SCID
Key exclusion criteria (5 listed)
- concomitant major internal or neurological illness
- concomitant psychiatric disorders (except depression and anxiety for patients, excluding PTSD, claustrophobia and bipolar disorder)
- ingestion of any antipsychotic, antidepressant, or anti-anxiety agent within the last three months prior to the screening visit
- current substance abuse
- failure to comply with the study protocol or to follow the instructions of the investigating team
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 |
|---|---|---|
| Escitalopram2-4 weeks, 5-10mg, max 20mg | Drug | Escitalopram |
Primary outcome
SSRI induced changes in BOLD (blood oxygen level dependent) response over time
Time frame: 4 vears
SSRI induced changes in ERPs (event-related potentials) over time
Time frame: 4 years
1 secondary outcome
biochemical data
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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 Escitalopram in people with Major Depressive Disorder (MDD) and Anxiety 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 11 inclusion and 5 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: finished, as of the sponsor's last update on 14 Sep 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SSRI induced changes in BOLD (blood oxygen level dependent) response over time (time frame: 4 vears). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2016.