NCT05243160

Brief Summary

This study aims to investigate the potential beneficial effects of a medication review by a clinical pharmacologist on patients with coexisting severe mental illness and diabetes. The study is an intervention study in which an intervention group is assigned to the medication review whereas a control group is not. Both groups are tested using an extensive test battery at baseline and 6 months after inclusion. Furthermore a qualitative data assessment will be undertaken using interviews and/or surveys in order to show any obstacles in implementing the intervention. This is relevant as medication reviews, performed by clinical pharmacologists as well as pharmacists, are not always implemented by the primary physician. The economic impact of the medication review will furthermore be assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

March 11, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2023

Completed
Last Updated

September 3, 2024

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

January 17, 2022

Last Update Submit

August 29, 2024

Conditions

SchizophreniaDiabetesMetabolic SyndromeSevere Mental DisorderMajor Depressive DisorderBipolar DisorderPsychosisPsychotic Disorders

Keywords

polypharmacymedication reviewmetabolic disorderdrug interactionpharmacologist/ or clinical pharmacology/ or pharmacology/drug interaction/adverse drug reaction/side effectmedication therapy management/pharmacovigilance/severe mental illness

Outcome Measures

Primary Outcomes (3)

  • Medicinal load

    Total amount of drugs prescribed

    6 months

  • Adverse drug interactions

    Amount of potential drug interactions

    6 months

  • Adverse side effects

    The number of potentiel drug related side effects

    6 months

Secondary Outcomes (8)

  • UKU side effect rating scale ("UKU" is a danish acronym for the "Task force for clinical investigations")

    6 months

  • SF-12 (short form survey)

    6 months

  • MARS (medication adherence rating scale).

    6 months

  • CGI (Clinical Global impression scale)

    6 months

  • PANSS-6 (positive and negative syndrome scale)

    6 months

  • +3 more secondary outcomes

Study Arms (2)

control

NO INTERVENTION

Treatment as usual

Intervention

EXPERIMENTAL

Intervention group will be exposed to a medication review by a clinical pharmacologist

Other: medication review

Interventions

medication reviewOTHER

The intervention consist of a medication review by a clinical pharmacologist.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients drafted must have diabetes (unspecified) and severe mental illness in this case schizophrenia, severe ADHD, anxiety, any other psychotic disorders or an affective disorder (e.g. bipolar disease and major depression). Patients are drafted from the "fusion clinic" in Slagelse Denmark which is a collaboration between endocrinologists and psychiatrists in the joint treatment of patients with diabetes and mental illness.
  • Only adult patients

You may not qualify if:

  • none of the above
  • Pediatric patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit for Psychotherapy and Psychopathology

Slagelse, 4200, Denmark

Location

MeSH Terms

Conditions

SchizophreniaDiabetes MellitusMetabolic SyndromeMental DisordersDepressive Disorder, MajorBipolar DisorderPsychotic DisordersMetabolic DiseasesDrug-Related Side Effects and Adverse Reactions

Interventions

Medication Review

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersGlucose Metabolism DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinismDepressive DisorderMood DisordersBipolar and Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Officials

  • Gesche Jürgens, MD

    Consultant physician

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2022

First Posted

February 16, 2022

Study Start

March 11, 2022

Primary Completion

October 27, 2023

Study Completion

October 27, 2023

Last Updated

September 3, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)