Condition 1: Schizophrenia. Condition 2: Schizoaffective disorders. Schizophrenia Schizoaffective disorders
Conditions
Interventions
Intervention 1: Intervention group: Patients in the intervention group are initially treated with 40 mg of pyridoxine once a day, then if tolerated, 40 mg twice a day for 3 days, and the dose is incre
Sponsors
Arak University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Definitive diagnosis of chronic schizophrenia or schizoaffective disorder based on DSM-V TR criteria by a specialist psychiatrist. Under treatment with stable antipsychotic medications (at least 3 months before the start of the study without change in dose or type of medication). Ability to understand, read and sign the informed consent form by the patient or legal guardian Do not use supplements containing vitamin B6 in amounts exceeding the standard daily dose (100mg). Adherence to treatment and the possibility of follow-up throughout the study (for example, patients who live in a fixed location and have access to treatment centers) Score of at least 32 on the PANSS questionnaire Not pregnant or breastfeeding (for female patients) Absence of severe or unstable internal diseases that can affect the absorption and metabolism of vitamin B6, including: advanced liver and kidney diseases (e.g., kidney failure), uncontrolled diabetes, metabolic disorders such as porphyria (which is associated with B6 metabolism). Failure to diagnose other psychiatric disorders (except schizophrenia and schizoaffective disorder) such as bipolar disorder type 1, schizotypal disorder, or substance-induced psychosis. No initiation or dose change of other psychiatric medication in the past 3 months (except in exceptional cases determined by the research team) No history of allergy to vitamin B6 or supplements containing it Lack of patients undergoing active psychotherapy, which may affect the results Not taking vitamin supplements
Exclusion criteria
Exclusion criteria: Withdrawal from the study or lack of cooperation from the patient (for example, failure to take medications or failure to attend assessment sessions). Developing a new serious illness that makes it impossible to continue participating in the study (such as stroke, acute renal failure, severe infection, etc.) Severe side effects associated with vitamin B6 such as peripheral neuropathy, severe allergic reactions, or other serious symptoms Changes in the dose or type of antipsychotic medication during the study (as this could confound the results) New diagnosis of other psychotic disorders or substance use disorders during the study Inability to follow up with the patient (e.g., change of location, hospitalization in another hospital without access to the research team)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Persian translation of the Positive and Negative Schizophrenia Symptom Scale (PANSS). Timepoint: At the beginning of the study and at weeks 5 and 10. Method of measurement: Filling out the Positive and Negative Schizophrenia Symptom Scale (PANSS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDavood Radsar
Arak University of Medical Sciences
Outcome results
None listed