NCT04507555 Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy
| NCT ID | NCT04507555 |
| Status | Recruiting |
| Phase | — |
| Sponsor | PD Dr. med. Thorsten Mikoteit |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2020-09-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 190 participants in total. It began in 2020-09-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * ≥ 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 Exclusion Criteria: * 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
Contact & Investigator
Thorsten Mikoteit, PD Dr. med.
PRINCIPAL INVESTIGATOR
Psychiatrische Dienste Solothurn
Frequently Asked Questions
Who can join the NCT04507555 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04507555 currently recruiting?
Yes, NCT04507555 is actively recruiting participants. Contact the research team at celine.staeuble@unibas.ch for enrollment information.
Where is the NCT04507555 trial being conducted?
This trial is being conducted at Münchenbuchsee, Switzerland, Solothurn, Switzerland, Sankt Urban, Switzerland, Zurich, Switzerland.
Who is sponsoring the NCT04507555 clinical trial?
NCT04507555 is sponsored by PD Dr. med. Thorsten Mikoteit. The principal investigator is Thorsten Mikoteit, PD Dr. med. at Psychiatrische Dienste Solothurn. The trial plans to enroll 190 participants.
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