Quality of Life, Safety and Compliance of Patients Using Monotherapy or Combinatorial Therapy With Quetiapine for Treatment of Schizophrenia or Bipolar Affective Disorder

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorBosnalijek D.D

About this trial

The goal of this observational study is to evaluate the quality of life, drug safety and therapy compliance of schizophrenia or bipolar affective disorder patients during the treatment with quetiapine monotherapy or in combination with another antipsychotic/antipsychotics. The main outcome measures are:

* quality of life using the World Health Organization Quality of Life questionnaire (WHOQOL) * safety through the monitoring of the incidence of possible adverse drug events by the researcher, with the assessment of the association between the administration of the drug and the occurrence of an adverse reaction * therapy adherence using the Medication Adherence Rating Scale (MARS).

The subjects will be divided into two groups:

1. Newly diagnosed patients with a diagnosis of schizophrenia or bipolar affective disorder whose individual therapeutic approach, based on the clinical assessment of the research physician, includes one of the following therapies:

1. monotherapy with the drug quetiapine 2. combined antipsychotic therapy with quetiapine and aripiprazole 3. combined antipsychotic therapy with quetiapine and haloperidol 2. Patients with a diagnosis of schizophrenia or bipolar affective disorder who are on therapy with one of the antipsychotics (aripiprazole or haloperidol), and who, based on the clinical assessment of the investigator, require adjunctive quetiapine therapy. This group will include two subgroups of patients:

1. combined antipsychotic therapy with quetiapine and aripiprazole 2. combined antipsychotic therapy with quetiapine and haloperidol Recruitment of subjects will be carried out by physicians/researchers based on the patient's history and diagnosis. The diagnosis of schizophrenia or bipolar affective disorder will be based on the standard diagnostic criteria in medical practice (validated measurement scales in psychiatry - Young's Mania Scale, Beck Depression Scale and PANNS Schizophrenia Scale).

Patients will have four visits to physician/researcher:

1. First visit - baseline at which patient will be included in the study 2. Second visit - 4 months after the baseline 3. Third visit - 8 months after the baseline 4. Fourth visit - 12 months after the baseline

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Persons over 18 years of age and under 65 years of age.

Schizophrenia or bipolar affective disorder established by the usual diagnostic criteria applied in a psychiatric clinic or hospital ward/unit within the clinic or outpatient.

Patients who are treated as outpatients, inpatients or have been discharged from the clinic/hospital with a recommendation for quetiapine monotherapy or combination therapy of quetiapine with aripiprazole or haloperidol. Recommended by a specialist psychiatrist/neuropsychiatrist in clinical and hospital centers and through specialist-consultant outpatient clinics in Bosnia and Herzegovina.

Disqualifiers

Persons younger than 18 years and older than 65 years

Hypersensitivity to the components of the drug

Positive history of angioneurotic edema

Pregnancy

Trial population

Schizophrenia or bipolar affective disorder patients of both sexes aged 18 to 65 years.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Quetiapine (drug)

    Drug

    Monotherapy with the drug quetiapine

  • quetiapine + aripiprazole

    Drug

    Combined antipsychotic therapy with quetiapine and aripiprazole

  • quetiapine + haloperidol

    Drug

    Combined antipsychotic therapy with quetiapine and haloperidol

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Newly diagnosed patients3 interventions
Group B: Previously diagnosed patients2 interventions

Trial outcomes

Primary outcomes

1

Measurement of quality of life using the World Health Organization Quality of Life questionnaire (WHOQOL)

Evaluation of the quality of life of patients during treatment for schizophrenia or bipolar affective disorder using monotherapy with the drug quetiapine or combination therapy with the drug quetiapine and another antipsychotic (aripiprazole or haloperidol).

Time frame
12 months from inclusion into the study (baseline)

Secondary outcomes

1

Safety assessment through incidence of possible adverse drug events and evaluation of the association between the administration of the drug and the occurrence of an adverse reaction

Safety through the monitoring of the incidence of possible adverse drug events by the researcher, with the assessment of the association between the administration of the drug and the occurrence of an adverse reaction

Time frame
12 months from baseline
2

Therapy adherence using the Medication Adherence Rating Scale (MARS)

Time frame
12 months from baseline

Other outcomes

Sponsors and contacts

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