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

9. oktober 2026 oppdatert av: Bosnalijek D.D

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).

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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Bosnia og Herzegovina
      • Sarajevo, Bosnia og Herzegovina, 71000
        • Rekruttering
        • Clinic of Psychiatry, University Clinical Center of Sarajevo
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Newly diagnosed patients

Newly diagnosed patients with a diagnosis of schizophrenia or bipolar affective disorder
Legemiddel: Quetiapine (drug)

Monotherapy with the drug quetiapine

Legemiddel: quetiapine + aripiprazole

Combined antipsychotic therapy with quetiapine and aripiprazole

Legemiddel: quetiapine + haloperidol

Combined antipsychotic therapy with quetiapine and haloperidol
Previously diagnosed patients

Patients with a previous diagnosis of schizophrenia or bipolar affective disorder
Legemiddel: quetiapine + aripiprazole

Combined antipsychotic therapy with quetiapine and aripiprazole

Legemiddel: quetiapine + haloperidol

Combined antipsychotic therapy with quetiapine and haloperidol

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Measurement of quality of life using the World Health Organization Quality of Life questionnaire (WHOQOL)-BREF
Tidsramme: 12 months from inclusion into the study (baseline)

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.
12 months from inclusion into the study (baseline)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 12 months from baseline

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
12 months from baseline
Therapy adherence using the Medication Adherence Rating Scale (MARS)
Tidsramme: 12 months from baseline

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.
12 months from baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bosnalijek D.D

Etterforskere

  • Hovedetterforsker: Gorana Sulejmanpašić, PhD, Clinic of Psychiatry, University Clinical Center of Sarajevo
  • Hovedetterforsker: Amra Memić Serdarević, PhD, Clinic of Psychiatry, University Clinical Center of Sarajevo

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. oktober 2025

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

1. mai 2027

Datoer for studieregistrering

Først innsendt

29. september 2026

Først innsendt som oppfylte QC-kriteriene

29. september 2026

Først lagt ut (Faktiske)

5. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KVP-01-2024

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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