Clinical Study Evaluating Pharmacogenomics-informed Pharmacotherapy Versus Dosing as Usual in Psychiatric Disorders

Part of paid clinical trials in Syracuse, New York.

Sponsor
Parnassia Groep
Study ID
NCT05656469
Status
Recruiting
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Conditions

  • Anxiety Disorders
  • Mood Disorders
  • Psychotic Disorders

Eligibility Criteria

Sex
ALL
Age
16 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Personalised medication advice based on pharmacogenetic testing — OTHER
    Pharmacogenetic genotyping provides personalised medication advice on dosage and choice of currently available and legally approved medication based on the patient's pharmacogenetic profile

Study Details

A 24-week, patient- and rater-blinded, two-arm, parallel-group controlled, and multi-centre randomized clinical trial (RCT) to establish the benefits of pharmacogenetics-informed pharmacotherapy versus dosing as usual (DAU) in psychiatric patients suffering from mood, anxiety, or psychotic disorders.

Key Dates

Start date
Feb 23, 2023
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
2,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PSY-PGx Group
    This is the intervention group. All patients will be treated according to a personalised medication recommendation based on the results of pharmacogenetic testing, following the prespecified dosing guideline. Prescribing physicians will prescribe one of the predefined drugs and will be unblinded for genotype and the resulting metabolisation phenotype.
  • No Intervention: Dosing as usual (DAU) group
    This is the control group. In this group, prescribing physicians will also prescribe one of the predefined drugs, but will remain blinded to their patients' genotype and resulting metabolism phenotype for the duration of their participation in the study. After the study, patients in the control group will also be given their pharmacogenetic profile, which will make it possible to personalise their medication if necessary.

Primary Outcome Measure

Patient recovery, as assessed using the Patient Recovery Assessment scale - Domains and Stages (RAS-DS). [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SUNY Upstate Medical University, Department of Psychiatry and Behavioural SciencesSyracuseNew York13210
Thomas Schulze, Prof. Dr.
Thomas Schulze, Prof. Dr. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Syracuse, NY

By research site
SUNY Upstate Medical University, Department of Psychiatry and Behavioural Sciences· Syracuse, NY

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