SchizophreniaNCT07858565
Quality of Life, Safety and Compliance of Patients Using Monotherapy or Combinatorial Therapy With Quetiapine for Treatment of Schizophrenia or Bipolar Affective Disorder
An observational study of Schizophrenia and Bipolar Affective Disorder, run by Bosnalijek D.D at 1 site in Bosnia and Herzegovina.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Bipolar Affective Disorder
- What is being tested?
- Quetiapine (drug), quetiapine + aripiprazole and quetiapine + haloperidol
- How many people
- 500 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 30 Oct 2025to May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Schizophrenia or bipolar affective disorder patients of both sexes aged 18 to 65 years.
Who may be able to join
- 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.
Who cannot join
- Persons younger than 18 years and older than 65 years
- Hypersensitivity to the components of the drug
- Positive history of angioneurotic edema
- Pregnancy
- Breastfeeding
- Simultaneous use with cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azole antifungals, erythromycin, clarithromycin and nefazodone
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- Patients who are planning to become pregnant in the near future
- Diagnosed medical conditions that may constitute a contraindication for the use of the drug quetiapine
- Withdrawal Criteria:
- Deterioration of the underlying disease that requires therapy discontinuation
- Development of serious adverse events requiring therapy discontinuation
- Occurence of pregnancy
- Development of another disease that affects the course of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
Clinic of Psychiatry, University Clinical Center of Sarajevo
Sarajevo, 71000
Gorana Sulejmanpašić, PhD, +38733297359, psihijatrija@kcus.ba
About this study
Official title: Study of Quality of Life, Safety and Compliance During Treatment of Schizophrenia or Bipolar Affective Disorder, in Patients Using the Drug Kvepin® (Quetiapine) as Monotherapy or Combination Therapy With Other Antipsychotics (Ispitivanje Kvalitete života, Sigurnosti i Saradljivosti u Toku liječenja Shizofrenije Ili Bipolarnog Afektivnog poremećaja, Kod Pacijenata Koji Koriste Lijek Kvepin® (Kvetiapin) Kao Monoterapiju Ili Kombinovanu Terapiju sa Drugim Antipsihoticima)
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).
Read more
The subjects will be divided into two groups:
- 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:
- monotherapy with the drug quetiapine
- combined antipsychotic therapy with quetiapine and aripiprazole
- combined antipsychotic therapy with quetiapine and haloperidol
- 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:
- combined antipsychotic therapy with quetiapine and aripiprazole
- 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:
- First visit - baseline at which patient will be included in the study
- Second visit - 4 months after the baseline
- Third visit - 8 months after the baseline
- Fourth visit - 12 months after the baseline
- Conditions
- Schizophrenia, Bipolar Affective Disorder
- Being tested
- Quetiapine (drug), quetiapine + aripiprazole, quetiapine + haloperidol
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine (drug)Drug
Monotherapy with the drug quetiapine
quetiapine + aripiprazoleDrug
Combined antipsychotic therapy with quetiapine and aripiprazole
quetiapine + haloperidolDrug
Combined antipsychotic therapy with quetiapine and haloperidol
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed patients | Newly diagnosed patients with a diagnosis of schizophrenia or bipolar affective disorder Receives: Drug: Quetiapine (drug); Drug: quetiapine + aripiprazole; Drug: quetiapine + haloperidol | |
| Previously diagnosed patients | Patients with a previous diagnosis of schizophrenia or bipolar affective disorder Receives: Drug: quetiapine + aripiprazole; Drug: quetiapine + haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of quality of life using the World Health Organization Quality of Life questionnaire (WHOQOL)-BREF
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). World Health Organization Quality of Life questionnaire (WHOQOL)-BREF will be used. It consists of 26 items that evaluate an individual's perception of their quality of life and consists of four domains: physical health (e.g., pain, energy, sleep, mobility, activities of daily living, work capacity); psychological health (e.g., positive and negative feelings, self-esteem, body image, cognition, spirituality); social relationships (e.g., personal relationships and social support) and environment. Domain scores are calculated according to the WHO scoring guidelines and can be transformed to a 0-100 scale, where higher scores represent a better quality of life.
Measured: 12 months from inclusion into the study (baseline)
Secondary outcomes (2)
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
Measured: 12 months from baseline
Therapy adherence using the Medication Adherence Rating Scale (MARS)
Medication Adherence Rating Scale (MARS), a validated self-report questionnaire designed to evaluate patients' adherence to prescribed medication regimens. The instrument was originally developed for patients receiving long-term pharmacological treatment and has been widely used in studies of psychiatric and chronic medical conditions. The MARS consists of 10 items that assess both medication-taking behavior and patients' attitudes toward medication, including forgetfulness, intentional omission of doses, discontinuation of treatment when feeling better or worse, and beliefs regarding the effects of medication. Responses are provided in a dichotomous (Yes/No) format. Individual item scores are summed to obtain a total score ranging from 0 to 10, with higher scores indicating better medication adherence. The scale enables the identification of both intentional and unintentional non-adherence and provides insight into factors affecting treatment adherence.
Measured: 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start30 Oct 2025
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bosnalijek D.D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gorana Sulejmanpašić, PhD, Principal investigator, Clinic of Psychiatry, University Clinical Center of SarajevoAmra Memić Serdarević, PhD, Principal investigator, Clinic of Psychiatry, University Clinical Center of Sarajevo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858565
- Sponsor's protocol ID
- KVP-01-2024
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No