DepressionPrePGxNCT04507555
Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy
A study testing Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing in people with Depression, run by PD Dr. med. Thorsten Mikoteit at 4 sites in Switzerland.
Trial summary
In this study at the Solothurn Psychiatric Clinic, the investigators compare the effectiveness and tolerability of antidepressant pharmacotherapy in three groups. In the intervention group, the physician selects and doses the medication for depression based on a pharmacogenetic examination conducted by a clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 15 Sep 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Diagnosis unipolar moderate or severe depressive episode or recurrent depressive disorder (ICD10: F32.1/32.2/33.1/33.2)
- HAM-D17 ≥ 17
Who cannot join
- Acute suicide risk
- Psychotic symptomatology
- Other acute serious psychiatric disorder other than depression
- Excessive consumption of alcohol and/or drugs
- Severe acute - or severe chronic somatic diseases
- Pregnant / lactating women
- Under current treatment with fluoxetine
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland4 sites, 4 recruiting
- Recruiting
Privatklinik Wyss
Münchenbuchsee, Canton of Bern, 3053
Christian Imboden, Dr. med., +4131 868 33 33, info@privatklinik-wyss.ch
- Recruiting
Luzerner Psychiatrie AG
Sankt Urban, 4915
Jochen Mutschler, Prof. Dr., +41 58 856 55 55, jochen.mutschler@lups.ch
- Recruiting
Psychiatrische Dienste Solothurn
Solothurn, Canton of Solothurn, 4503
Thorsten Mikoteit, PD Dr. med., +41 32 627 11 11, thorsten.mikoteit@spital.so.ch
- Recruiting
Psychiatrische Universitätsklinik Zürich
Zurich, 8032
Sebastian Olbrich, Dr., +41 58 384 21 11, sebastian.olbrich@pukzh.ch
About this study
In this study at the Solothurn Psychiatric Clinic, the investigators compare the effectiveness and tolerability of antidepressant pharmacotherapy in three groups. In the intervention group, the physician selects and doses the medication for depression based on a pharmacogenetic examination conducted by a clinical pharmacist. In the standard group, the treating physician selects and doses the antidepressant drug without the support of genetic testing, in accordance with current standard practice. If after the first week of hopsitalization no adjustment to a new antidepressant is necessary, the investigators will monitor the progress of these patients until they leave the clinic in an observational arm. The drugs used are all approved in Switzerland for the treatment of depression. Classification into the intervention or standard group is made randomly after the first week of hospitalisation, if the treating physician deems it necessary to change or readjust the antidepressant pharmacotherapy. The probability of allocation to one of the two study groups is 50%. All study participants will be hospitalized for at least five weeks and monitored until they leave the clinic. In total, it is planned to include and examine 95 patients each into the intervention and standard group.
- Conditions
- Depression
- Being tested
- Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing, Standard care antidepressant selection and dosing
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosingProcedure or surgery
The study intervention is the service of pharmacist guided pre-emptive PGx testing to support clinical decision making for antidepressant selection and dosing.
This service involves genotyping and thereof evidence-based genotype interpretation commercially offered as Stratipharm® (humatrix AG, Pfungstadt Germany, https://www.stratipharm.de). Furthermore, clinical pharmacists will process and evaluate the results from PGx testing (Stratipharm®) in context of the individual patient medication history as well as current co-medication and forward an individualized recommendation for antidepressant selection and dosing to the treating psychiatrist.
Standard care antidepressant selection and dosingProcedure or surgery
Selection and dosing of the new antidepressant pharmacotherapy will be determined by the treating investigator alone, according to current standard of care considering clinical factors only.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Procedure: Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing |
| Standard Care | Active comparator | Not described Receives: Procedure: Standard care antidepressant selection and dosing |
| Observational | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of response to the antidepressant therapy at the end of week 4
response is determined as a reduction in the Hamilton Depression (HAM-D17) Scale score of at least 50 % of the baseline value
Measured: 28 days
Secondary outcomes (7)
Time to response
time span from start of antidepressant pharmacotherapy until first assessed response (= HAM-D17 reduction of at least 50 % compared to baseline
Measured: 28 days
Remission rate
17 item Hamilton rating scale for Depression (HAM-D17) score ≤ 8
Measured: 28 days
Overall change in 17 item Hamilton rating scale for Depression (HAM-D17) from baseline to week 4
minimum value: 0, maximum value: 52 ; higher scores mean worse outcome
Measured: 28 days
Time till discharge
time span from admission (randomization) to discharge from inpatient treatment
Measured: assessed up to 3 month
Patient depression self-rating
two weekly assessment with Beck's Depression Inventory questionnaire (BDI-II)
Measured: 28 days
Side effect measure (self-rated frequency, intensity and burden of side effects, FIBSER score)
weekly assessment, minimum value: 0, maximum value: 18 ; higher scores mean worse outcome
Measured: 28 days
Number of adverse events related to antidepressant pharmacotherapy
severity grading ≥ 2 (using CTCAE version 5.0) and causality to antidepressant pharmacotherapy assessed as possible, probable or definite
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start15 Sep 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PD Dr. med. Thorsten Mikoteit
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatrische Dienste Solothurn, Privatklinik Wyss, Luzerner Psychiatrie AG, Psychiatrische Universitätsklinik Zürich
- Responsible party
- Sponsor-investigator, PD Dr. med. Thorsten Mikoteit, University of Basel
- Investigators
- Thorsten Mikoteit, PD Dr. med., Principal investigator, Psychiatrische Dienste Solothurn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507555
- Sponsor's protocol ID
- PrePGx_ex20Mikoteit
- Acronym
- PrePGx
- Status last verified
- Jan 2025
- First submitted
- 4 Aug 2020
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stauble CK, Lampert ML, Allemann S, Hatzinger M, Hersberger KE, Meyer Zu Schwabedissen HE, Imboden C, Mikoteit T. Pharmacist-guided pre-emptive pharmacogenetic testing in antidepressant therapy (PrePGx): study protocol for an open-label, randomized controlled trial. Trials. 2021 Dec 14;22(1):919. doi: 10.1186/s13063-021-05724-5.
PubMed 34906208
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy
- ClinicalTrials.gov ID
- NCT04507555
- Acronym / sponsor ID
- PrePGx / PrePGx_ex20Mikoteit
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- PD Dr. med. Thorsten MikoteitUniversity, hospital or other
- Collaborators
- Psychiatrische Dienste Solothurn, Privatklinik Wyss, Luzerner Psychiatrie AG, Psychiatrische Universitätsklinik Zürich
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Aug 2020 (actual)
- 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.
In this study at the Solothurn Psychiatric Clinic, the investigators compare the effectiveness and tolerability of antidepressant pharmacotherapy in three groups. In the intervention group, the physician selects and doses the medication for depression based on a pharmacogenetic examination conducted by a clinical pharmacist. In the standard group, the treating physician selects and doses the antidepressant drug without the support of genetic testing, in accordance with current standard practice. If after the first week of hopsitalization no adjustment to a new antidepressant is necessary, the investigators will monitor the progress of these patients until they leave the clinic in an observational arm. The drugs used are all approved in Switzerland for the treatment of depression. Classification into the intervention or standard group is made randomly after the first week of hospitalisation, if the treating physician deems it necessary to change or readjust the antidepressant pharmacotherapy. The probability of allocation to one of the two study groups is 50%. All study participants will be hospitalized for at least five weeks and monitored until they leave the clinic. In total, it is planned to include and examine 95 patients each into the intervention and standard group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing |
| Standard Care | Active comparator | Procedure: Standard care antidepressant selection and dosing |
| Observational | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Diagnosis unipolar moderate or severe depressive episode or recurrent depressive disorder (ICD10: F32.1/32.2/33.1/33.2)
- HAM-D17 ≥ 17
Key exclusion criteria (7 listed)
- Acute suicide risk
- Psychotic symptomatology
- Other acute serious psychiatric disorder other than depression
- Excessive consumption of alcohol and/or drugs
- Severe acute - or severe chronic somatic diseases
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 |
|---|---|---|
| Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosingThe study intervention is the service of pharmacist guided pre-emptive PGx testing to support clinical decision making for antidepressant selection and dosing. This service involves genotyping and thereof evidence-based genotype interpretation commercially offered as Stratipharm® (humatrix AG, Pfungstadt Germany, https://www.stratipharm.de). Furthermore, clinical pharmacists will process and evaluate the results from PGx testing (Stratipharm®) in context of the individual patient medication history as well as current co-medication and forward an individualized recommendation for antidepressant selection and dosing to the treating psychiatrist. | Procedure or surgery | Intervention |
| Standard care antidepressant selection and dosingSelection and dosing of the new antidepressant pharmacotherapy will be determined by the treating investigator alone, according to current standard of care considering clinical factors only. | Procedure or surgery | Standard Care |
Primary outcome
rate of response to the antidepressant therapy at the end of week 4
Time frame: 28 days
response is determined as a reduction in the Hamilton Depression (HAM-D17) Scale score of at least 50 % of the baseline value
7 secondary outcomes
Time to response
Time frame: 28 days
Remission rate
Time frame: 28 days
Overall change in 17 item Hamilton rating scale for Depression (HAM-D17) from baseline to week 4
Time frame: 28 days
Time till discharge
Time frame: assessed up to 3 month
Patient depression self-rating
Time frame: 28 days
Side effect measure (self-rated frequency, intensity and burden of side effects, FIBSER score)
Time frame: 28 days
Number of adverse events related to antidepressant pharmacotherapy
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Derived from this study: PubMed 34906208Stauble CK, Lampert ML, Allemann S, Hatzinger M, Hersberger KE, Meyer Zu Schwabedissen HE, Imboden C, Mikoteit T. Pharmacist-guided pre-emptive pharmacogenetic testing in antidepressant therapy (PrePGx): study protocol for an open-label, randomized controlled trial. Trials. 2021 Dec 14;22(1):919. doi: 10.1186/s13063-021-05724-5.
- Individual participant dataSharing planned: No
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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.
Thorsten Mikoteit, PD Dr. med. principal investigator
Psychiatrische Dienste Solothurn
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing in people with Depression, run by PD Dr. med. Thorsten Mikoteit at 4 sites in Switzerland.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Céline Stäuble, MSc (+41 61 207 61 78, celine.staeuble@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of response to the antidepressant therapy at the end of week 4 (time frame: 28 days). 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 NCT04507555, which also lists 1 linked publication.
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 20 Jan 2025.