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Het monitoren van bijwerkingen van geneesmiddelen op de poliklinieken van GGZ Drenthe/Monitoring of side effects of medication at outpatient departments of Mental Health Services Drenthe


- candidate number20997
- NTR NumberNTR4918
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-nov-2014
- Secondary IDsNL49698.099.14; RTPO 928 CCMO (Toetsingonline; ABR form); rTPO Leeuwarden
- Public TitleHet monitoren van bijwerkingen van geneesmiddelen op de poliklinieken van GGZ Drenthe/Monitoring of side effects of medication at outpatient departments of Mental Health Services Drenthe
- Scientific Title‘Monitoring Outcomes of Psychiatric Pharmacotherapy in the Assen Region’ (MOPHAR) Phase 2 – a prospective observational cohort study
- ACRONYMMOPHAR
- hypothesisPsychiatric patients often have somatic comorbidities and other risk factors that render them vulnerable to the diverse and severe side effects of psychiatric pharmacotherapy. In outpatient clinics of institutions of Mental Health Services (MHS; in Dutch: GGZ) in the Netherlands it is suggested that information regarding effectiveness of the prescribed drugs is not routinely collected using standardised monitoring protocols. It therefore is unclear to which extent the drugs used by the patients visiting these outpatient clinics are prescribed effectively and safely.
In the project ‘Monitoring Outcomes of Pharmacotherapy in the Assen Region’ (MOPHAR), an infrastructure will be created in which - using standardised protocols - longitudinal monitoring data will be collected regarding Routine Outcome Monitoring (ROM), medication usage and monitoring of side effects of psychiatric pharmacotherapy in outpatients at MHS Drenthe, thereby enabling research to investigate associations between patient characteristics and outcomes (e.g. efficacy, (cost)effectiveness, profiles of adverse effects) of psychiatric pharmacotherapy and associations between the use of specific psychotropic drugs and adverse outcomes like metabolic abnormalities.
- Healt Condition(s) or Problem(s) studiedPsychiatric disorders, Anxiety disorders, Mood disorders, Metabolic syndrome
- Inclusion criteriaIn order to be eligible to participate in MOPHAR research, a subject must meet all of the following criteria:
• Visiting an outpatient department of MHS Drenthe (first time or follow-up visit);
• Older than 18 years of age;
• Signed informed consent;
- Exclusion criteriaIn general, there are no exclusion criteria for inclusion in the MOPHAR cohort.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-jan-2015
- planned closingdate1-jan-2018
- Target number of participants10000
- InterventionsN/A
- Primary outcomeThe efficacy, (cost)effectiveness and safety of psychiatric pharmacotherapy (after implementation of a monitoring programme):
- monitoring outcomes, such as antropometric examinations, blood parameters, etc.
- score on psychiatric questionnaires
- patient characteristics such as pharmacogenetics or biomarker levels
- medication usage
Specific primary and secondary study parameters will be determined for each individual research question.
- Secondary outcomeFor example time (e.g. duration of psychotropic drug usage, duration of treatment at the outpatient department), costs, medication adherence, etc.
- TimepointsAll patiënts will undergo somatic screening and medication reconciliation at baseline and will be asked to fill in a couple of questionnaires following protocol. Patients will be followed during the rest of their treatment at the outpatient department following specific protocols depending on the psychotropic medication usage.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M. Simoons
- CONTACT for SCIENTIFIC QUERIES M. Simoons
- Sponsor/Initiator GGZ Drenthe
- Funding
(Source(s) of Monetary or Material Support)
GGZ Drenthe
- Publications
- Brief summaryRationale: Psychiatric patients often have somatic comorbidities and other risk factors that render them vulnerable to the diverse and severe side effects of psychiatric pharmacotherapy. In outpatient clinics of institutions of Mental Health Services (MHS; in Dutch: GGZ) in the Netherlands it is suggested that information regarding effectiveness of the prescribed drugs is not routinely collected using standardised monitoring protocols. It therefore is unclear to which extent the drugs used by the patients visiting these outpatient clinics are prescribed effectively and safely. Objectives: In the project ‘Monitoring Outcomes of Pharmacotherapy in the Assen Region’ (MOPHAR), an infrastructure will be created in which - using standardised protocols - longitudinal monitoring data will be collected regarding Routine Outcome Monitoring (ROM), medication usage and monitoring of side effects of psychiatric pharmacotherapy in outpatients at MHS Drenthe, thereby enabling research. Research objectives are:
1. To investigate the association between patient characteristics and outcomes (e.g. efficacy, (cost)effectiveness, profiles of adverse effects) of psychiatric pharmacotherapy. Among others the association between biomarkers/ pharmacogenetic determinants and the prevalence of adverse events of antidepressants will be investigated.
2. To investigate the association between the use of specific psychotropic drugs and adverse outcomes like metabolic abnormalities.
Study design: Prospective observational cohort study
. Study population: All newly referred and current adult patients from outpatient departments of MHS Drenthe, starting with patients from the Mood and Anxiety Disorder team in Emmen.
Main study parameters/endpoints: The efficacy, (cost)effectiveness and safety of psychiatric pharmacotherapy (after implementation of a monitoring programme).
- Main changes (audit trail)
- RECORD19-nov-2014 - 15-jan-2016


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