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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 aktualisiert von: 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

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

500

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Bosnien und Herzegowina
      • Sarajevo, Bosnien und Herzegowina, 71000
        • Rekrutierung
        • Clinic of Psychiatry, University Clinical Center of Sarajevo
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Newly diagnosed patients

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

Monotherapy with the drug quetiapine

Arzneimittel: quetiapine + aripiprazole

Combined antipsychotic therapy with quetiapine and aripiprazole

Arzneimittel: quetiapine + haloperidol

Combined antipsychotic therapy with quetiapine and haloperidol
Previously diagnosed patients

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

Combined antipsychotic therapy with quetiapine and aripiprazole

Arzneimittel: quetiapine + haloperidol

Combined antipsychotic therapy with quetiapine and haloperidol

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Measurement of quality of life using the World Health Organization Quality of Life questionnaire (WHOQOL)-BREF
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Bosnalijek D.D

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. Oktober 2025

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. Mai 2027

Studienanmeldedaten

Zuerst eingereicht

29. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. September 2026

Zuerst gepostet (Tatsächlich)

5. Oktober 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KVP-01-2024

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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