schizophrenia. Schizophrenia
Conditions
Interventions
Intervention group: Patients are randomly assigned to three parallel groups with a 1:1:1 allocation ratio:Group 1) Buspirone + Risperidone – Risperidone (2-6 mg/day) Week 1: 5 mg three times per da
Sponsors
University of social welfare and rehabilitation sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Definitive diagnosis: Receiving a definitive diagnosis of schizophrenia according to DSM-5 criteria by a treating psychiatrist. Phase of illness: The patient must be in the remission phase of the illness, defined as relative stability of positive symptoms for four weeks prior to study entry (confirmed by the treating psychiatrist) Stable baseline treatment: The patient must have been on a stable dose of the antipsychotic medication risperidone (within the range of 2–6 mg/day) for at least four weeks before study entry. Severity of anxiety symptoms: Achieving a minimum score of 8 on the Hamilton Anxiety Rating Scale (HAM-A) during screening. Age range: Patient age between 18 and 65 years. No prohibited medications: No concurrent use of any other medication with known effects on the central nervous system (e.g., other benzodiazepines, antidepressants, mood stabilizers, other antipsychotics, or herbal medications with sedative effects). Informed consent: The patient's legal guardian must sign a written informed consent form, and the patient's verbal assent should also be obtained whenever possible.
Exclusion criteria
Exclusion criteria: Psychiatric emergency: Presence of suicidal thoughts, plan, or attempt in the past month, or aggressive behaviors and severe agitation. Unstable medical conditions: Presence of uncontrolled medical illnesses such as severe heart failure, severe renal failure, or severe liver failure that could interfere with the study process or the patient's participation in the research. Neurological disorders: Presence of active epilepsy, Parkinson's disease, dementia, etc. Intellectual disability: Comorbid diagnosis of intellectual disability. Substance use disorder: Comorbid diagnosis of substance use disorder (with the exception of nicotine). Drug hypersensitivity: Known history of hypersensitivity to buspirone, lorazepam, or other benzodiazepines. Occurrence of intolerable adverse effects: Occurrence of severe adverse effects due to the study medications (according to the operational definition in section 5-8). Non-adherence to treatment: Consumption of less than 80% of the prescribed doses of the study medication. Withdrawal: Withdrawal of consent by the patient's legal guardian to continue the patient's participation in the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of anxiety symptoms based on the Hamilton Anxiety Rating Scale (HAM-A) score. Timepoint: Before intervention with lorazepam, buspirone, and placebo (week 0), week 4, and week 8. Method of measurement: Hamilton Anxiety Rating Scale (HAM-A). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Severity of drug-related adverse effects: This is a qualitative (ordinal) variable. It will be assessed by the treating physician at weeks 4 and 8 using a pre-specified checklist. The adverse effects include: headache, drowsiness, imbalance, diarrhea, constipation, appetite changes, respiratory depression, nausea, agitation, pruritus, memory impairment, palpitations, tremor, dizziness, and lightheadedness.2. Comparison of treatment efficacy between groups: First comparison: Treatment effect of lorazepam + risperidone compared to placebo + risperidone Second comparison: Treatment effect of buspirone + risperidone compared to placebo + risperidone Third comparison: Treatment effect of lorazepam + risperidone compared to buspirone + risperidone. Timepoint: Week 4 and week 8. Method of measurement: 1. The standard Hamilton Anxiety Rating Scale (HAM-A) questionnaire, which is completed by the patient (or with the assistance of the researcher if necessary) at three time points: baseline (week 0, before the start of the intervention), week 4, and week 8.2. The drug adverse effects severity checklist, which is completed by the treating physician through clinical interview with the patient and, if necessary, physical examination at two time points: week 4 and week 8. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Porna Lotf
University of social welfare and rehabilitation sciences
Outcome results
None listed