Quality of life and safety in quetiapine use for schizophrenia or bipolar disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study monitors adults with schizophrenia or bipolar disorder who are prescribed quetiapine as monotherapy or in combination with another antipsychotic. Researchers will track quality of life using the WHOQOL instrument, monitor adverse events, and measure therapy adherence with the MARS scale. Participants are grouped by their treatment plan, as determined by their clinician, and followed in a real-world clinical setting in Bosnia and Herzegovina. Outcomes focus on patient-reported quality of life, safety signals, and adherence patterns over time. The study does not assign treatments but observes existing clinical practice to understand real-world tolerability and impact on daily living.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinic of Psychiatry, University Clinical Center of Sarajevo
  Sarajevo, Bosnia and Herzegovina Recruiting

Study contacts

• Principal investigator: Gorana Sulejmanpašić, PhD — Clinic of Psychiatry, University Clinical Center of Sarajevo
• Study coordinator: Halima Karakaš
• Email: HalimaK@Bosnalijek.ba
• Phone: +38762478535

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.