In the project *Monitoring Outcomes of Pharmacotherapy (MOPHAR), an infrastructure will be created in which - using standardised protocols - longitudinal monitoring data will be collected regarding Routine Outcome Monitoring (ROM), medication usage…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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 outcome
For example time (e.g. duration of psychotropic drug usage, duration of
treatment at the outpatient department), costs, medication adherence, etc.
Background summary
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.
Study objective
In the project *Monitoring Outcomes of Pharmacotherapy (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 in the Northern-Netherlands,
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 burden and risks
The burden for subjects consists of the collection of the extra blood sample
(10 mL). However, since the extra blood sample will be collected from the same
venapuncture as the blood sample(s) for medical treatment and the parameters
that will be investigated are measured as a part of routine clinical practice,
no extra risks are associated with participation in MOPHAR. The questionnaires
and computer task pose no additional burden. Treatment of subjects will not be
altered as a requirement for participation in MOPHAR research. Results of this
research project can be used to improve daily care at the outpatient
departments of MHSs.
Dennenweg 9
Assen 9404 LA
NL
Dennenweg 9
Assen 9404 LA
NL
Listed location countries
Age
Inclusion criteria
• Visiting an outpatient department of a participating mental health center
(first time or follow-up visit);
• Older than 18 years of age;
• Signed informed consent;
Exclusion criteria
None
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | NL4779 |
| CCMO | NL49698.099.14 |
| OMON | NL-OMON22977 |