Major DepressionPhase 4NCT02237937
Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene
A Phase 4 study testing Paroxetine, Sertraline and Citalopram in people with Major Depression, run by HolsboerMaschmeyer NeuroChemie GmbH at 1 site in Germany.
Trial summary
The study evaluates the ABCB1-genotype dependent efficacy of a quick dose-escalation strategy within 28 days of treatment with approved antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the blood-brain barrier expressed by the ABCB1 gene. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- What is being tested?
- Paroxetine, Sertraline and Citalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Dec 2014
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female patients
- Age between 18 and 80 years
- Inpatients with a DSM-IV diagnosis of Major Depression
- single episode or recurrent
- moderate to severe intensity
- without psychotic features
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- Inpatients with a DSM-IV diagnosis of bipolar disorder I or II
- current episode with depressive symptoms
- moderate to severe intensity
- without psychotic features
- HAM-D score at the time of inclusion in the study ≥ 14
- Patient has already been adjusted to one of the following antidepressants in a dose which is still under the defined normal-dose:
- paroxetine < 40 mg/d
- sertraline < 100 mg/d
- citalopram < 40 mg/d
- escitalopram < 20 mg/d
- venlafaxine < 225 mg/d
- amitriptyline < 150 mg/d
- amitriptylinoxide < 150 mg/d
- nortriptyline < 150 mg/d
- trimipramine < 150 mg/d
Who cannot join
- Acute suicidality (HAM-D Item 3 score > 2)
- Acute alcohol-, hypnotics-, analgesics- or psychopharmacological intoxication or delirium
- Current alcohol dependence, or dependencies from other psychotropic substances
- Severe medical or neurological diseases: patients with severe hepatic (severe impairment of liver function, cirrhosis of the liver), renal (kidney malfunctions), cardiovascular (recent myocardial infarction, instable heart disease), neurological diseases (e.g. multiple sclerosis, Parkinson, dementia)
- Patients incapable of giving informed consent
- Pregnant or breast-feeding women
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- Women of reproductive age without effective contraception
- Simultaneous participation in other clinical trials or participation in an other clinical trial within 6 weeks before the start of the study
- Hypersensitivity to the study medication or to one of the ingredients of the medication
- Simultaneous treatment with another antidepressant besides study medication (exception: trazodone up to 75 mg/d, mirtazapine up to 15 mg/d, trimipramine up to 50 mg/d)
- Simultaneous treatment with mood stabilizers or neuroleptic drugs (exception: quetiapine up to 50 mg/d, olanzapine up to 5 mg/d)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Max Planck Institute of Psychiatry
Munich, Bavaria, 80804
Barbara Breitenstein, MSc
About this study
The study evaluates the ABCB1-genotype dependent efficacy of a quick dose-escalation strategy within 28 days of treatment with approved antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the blood-brain barrier expressed by the ABCB1 gene.
Moreover, the study evaluates ABCB1-genotype dependent side-effects of approved antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the blood-brain barrier expressed by the ABCB1 gene.
- Conditions
- Major Depression
- Being tested
- Paroxetine, Sertraline, Citalopram, Venlafaxine, Amitriptyline
- Keywords
- Depression, Affective Disorder
- Medical subject headings
- Depressive Disorder, Major, Depression, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParoxetineDrug
SertralineDrug
CitalopramDrug
VenlafaxineDrug
AmitriptylineDrug
EscitalopramDrug
AmitriptylinoxideDrug
NortriptylineDrug
TrimipramineDrug
| Study group | Role | What they receive |
|---|---|---|
| Normal dosage | Experimental | Selected antidepressants that are substrates of the P-glycoprotein:
Dosage:
* paroxetine < 40 mg/d
* sertraline < 100 mg/d
* citalopram < 40 mg/d
* escitalopram < 20 mg/d
* venlafaxine < 225 mg/d
* amitriptyline < 150 mg/d
* amitriptylinoxide < 150 mg/d
* nortriptyline < 150 mg/d
* trimipramine < 150 mg/d Receives: Drug: Paroxetine; Drug: Sertraline; Drug: Citalopram; Drug: Venlafaxine; Drug: Amitriptyline; Drug: Escitalopram; Drug: Amitriptylinoxide; Drug: Nortriptyline; Drug: Trimipramine |
| High dosage | Experimental | Selected antidepressants that are substrates of the P-glycoprotein:
Dosage:
* paroxetine < 80 mg/d
* sertraline < 200 mg/d
* citalopram < 80 mg/d
* escitalopram < 40 mg/d
* venlafaxine < 450 mg/d
* amitriptyline < 300 mg/d
* amitriptylinoxide < 300 mg/d
* nortriptyline < 300 mg/d
* trimipramine < 300 mg/d Receives: Drug: Paroxetine; Drug: Sertraline; Drug: Citalopram; Drug: Venlafaxine; Drug: Amitriptyline; Drug: Escitalopram; Drug: Amitriptylinoxide; Drug: Nortriptyline; Drug: Trimipramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
25% improvement in the HAM-D
Partial response indicated by at least 25% improvement in the Hamilton Rating Scale for Depression (HAM-D)
Measured: after 28 days of treatment
Secondary outcomes (1)
side effects
UKU side effect scale, AMDP side effect scale
Measured: after 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startSep 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HolsboerMaschmeyer NeuroChemie GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Max-Planck-Institute of Psychiatry
- Responsible party
- Sponsor
- Investigators
- Florian Holsboer, MD, PHD, Principal investigator, Max-Planck-Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237937
- Sponsor's protocol ID
- 2011-003190-29
- Status last verified
- Sep 2014
- First submitted
- 26 Aug 2013
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene
- ClinicalTrials.gov ID
- NCT02237937
- Acronym / sponsor ID
- 2011-003190-29
- Conditions
- Major Depression
- Keywords
- Depression, Affective Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- HolsboerMaschmeyer NeuroChemie GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Max-Planck-Institute of Psychiatry
- Study start
- Sep 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 12 Sep 2014 (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.
The study evaluates the ABCB1-genotype dependent efficacy of a quick dose-escalation strategy within 28 days of treatment with approved antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the blood-brain barrier expressed by the ABCB1 gene.
Moreover, the study evaluates ABCB1-genotype dependent side-effects of approved antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the blood-brain barrier expressed by the ABCB1 gene.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal dosage | Experimental | Drug: Paroxetine, Drug: Sertraline, Drug: Citalopram, Drug: Venlafaxine, Drug: Amitriptyline, Drug: Escitalopram, Drug: Amitriptylinoxide, Drug: Nortriptyline, Drug: TrimipramineSelected antidepressants that are substrates of the P-glycoprotein: Dosage: * paroxetine < 40 mg/d * sertraline < 100 mg/d * citalopram < 40 mg/d * escitalopram < 20 mg/d * venlafaxine < 225 mg/d * amitriptyline < 150 mg/d * amitriptylinoxide < 150 mg/d * nortriptyline < 150 mg/d * trimipramine < 150 mg/d |
| High dosage | Experimental | Drug: Paroxetine, Drug: Sertraline, Drug: Citalopram, Drug: Venlafaxine, Drug: Amitriptyline, Drug: Escitalopram, Drug: Amitriptylinoxide, Drug: Nortriptyline, Drug: TrimipramineSelected antidepressants that are substrates of the P-glycoprotein: Dosage: * paroxetine < 80 mg/d * sertraline < 200 mg/d * citalopram < 80 mg/d * escitalopram < 40 mg/d * venlafaxine < 450 mg/d * amitriptyline < 300 mg/d * amitriptylinoxide < 300 mg/d * nortriptyline < 300 mg/d * trimipramine < 300 mg/d |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male and female patients
- Age between 18 and 80 years
- Inpatients with a DSM-IV diagnosis of Major Depression
- single episode or recurrent
- moderate to severe intensity
Key exclusion criteria (11 listed)
- Acute suicidality (HAM-D Item 3 score > 2)
- Acute alcohol-, hypnotics-, analgesics- or psychopharmacological intoxication or delirium
- Current alcohol dependence, or dependencies from other psychotropic substances
- Severe medical or neurological diseases: patients with severe hepatic (severe impairment of liver function, cirrhosis of the liver), renal (kidney malfunctions), cardiovascular (recent myocardial infarction, instable heart disease), neurological diseases (e.g. multiple sclerosis, Parkinson, dementia)
- Patients incapable of giving informed consent
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 |
|---|---|---|
| Paroxetine | Drug | High dosage, Normal dosage |
| Sertraline | Drug | High dosage, Normal dosage |
| Citalopram | Drug | High dosage, Normal dosage |
| Venlafaxine | Drug | High dosage, Normal dosage |
| Amitriptyline | Drug | High dosage, Normal dosage |
| Escitalopram | Drug | High dosage, Normal dosage |
| Amitriptylinoxide | Drug | High dosage, Normal dosage |
| Nortriptyline | Drug | High dosage, Normal dosage |
| Trimipramine | Drug | High dosage, Normal dosage |
Primary outcome
25% improvement in the HAM-D
Time frame: after 28 days of treatment
Partial response indicated by at least 25% improvement in the Hamilton Rating Scale for Depression (HAM-D)
1 secondary outcome
side effects
Time frame: after 28 days of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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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.
Florian Holsboer, MD, PHD principal investigator
Max-Planck-Institute of Psychiatry
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 Paroxetine, Sertraline and Citalopram in people with Major Depression, run by HolsboerMaschmeyer NeuroChemie GmbH at 1 site in Germany.
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 21 inclusion and 11 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 12 Sep 2014. 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 Germany. 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?
Contact Barbara Breitenstein, MSc (0049 89 30622 ext. 244, barbara_breitenstein@mpipsykl.mpg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25% improvement in the HAM-D (time frame: after 28 days of treatment). 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 12 Sep 2014; AzTrials last refreshed its copy on 7 Nov 2026.