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IRCT20101130005280N55 IRCT 2022-07-09 Gorgan University of Medical Sciences Effect of Folic Acid in Reducing Negative Symptoms of Male Schizophrenia Patients Evaluating the Effectiveness of Adjunctive Therapy Using Folic Acid in Reducing Negative Symptoms of Male Schizophrenia Patients 2022-07-23 anticipated 30 Complete https://irct.ir/trial/63078 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: This is how random numbers are prepared with the help of Randomaize.com. 30 envelopes, a number of aluminum-wrapped envelopes (in order to avoid the clarity of the contents of the envelopes), are prepared and each of the random sequences created is registered on a card and the cards are inserted into the deck. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants to the study, one of the envelopes of the letter is opened and the envelopes containing the number of odd or even are assigned to the control or intervention group, Blinding description: Subjects and clinical caregivers are fully aware of the subject of research and the purpose and process of the study, and after filling out the consent and according to the entry conditions, will enter the study of the contents of the envelope and to which group they are assigned (control and intervention) ( Because they do not predict the outcome) will be unaware. Take it and give it to the investigator. 3 Schizophrenia. Intervention 1: Intervention group: The intervention group received 5 mg folic acid tablets for six weeks. Symptom severity was evaluated according to PANSS criteria at baseline and weeks 2, 4, and 6. Data were then analyzed using SPSS. Intervention 2: Control group: The controls received a placebo for six weeks. Symptom severity was evaluated according to PANSS criteria at baseline and weeks 2, 4, and 6. Data were then analyzed using SPSS. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After finishing work, consult with colleagues and it will be published if all members
public Elahe Mehdi Zade
Hirkan Blv., Gorgan
Gorgan Iran (Islamic Republic of) 4918936316 +98 17 3247 0110 Raikaravan@gmail.com Gorgan University of Medical Sciences scientific Leila Kashani
Hirkan Blv., Gorgan
Gorgan Iran (Islamic Republic of) 4918936316 +98 17 3247 0110 Raikaravan@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Schizophrenia Diagnosis Based on V-DSM Diagnostic Criteria Absence of Extrapyramidal Symptoms Male Gender Age Between 18 to 50 Years Old Completing Informed Consent to Participate in the Study 18 years 50 years Male Clinically Prominent Neurological or Organic Disease Presence of Another Major I-Axis Diagnosis Based on V-DSM Abnormality in Previous Tests IQ Less than 70 Based on Standardized Tests History of Drug Use (Excluding Nicotine and Caffeine) ECT in the Past Two Weeks Oral Antipsychotics in the Past Week or Long-Acting Antipsychotics in the Past Month F20 Schizophrenia Treatment - Drugs Placebo Intervention group: The intervention group received 5 mg folic acid tablets for six weeks. Symptom severity was evaluated according to PANSS criteria at baseline and weeks 2, 4, and 6. Data were then analyzed using SPSS. Control group: The controls received a placebo for six weeks. Symptom severity was evaluated according to PANSS criteria at baseline and weeks 2, 4, and 6. Data were then analyzed using SPSS. Reducing Negative Symptoms. Timepoint: Before the intervention and after 6 weeks of drug use. Method of measurement: With PANSS test questionnaire, the process of improvement and reduction of symptoms is measured. Gorgan University of Medical Sciences Approved 2021-05-23 Ethics committee of Golestan University of Medical Sciences Gorgan - the beginning of Shast Kola Road - Higher Education Complex of the Philosophical Deceased - Gorgan Medical School. Gorgan Golestan Iran (Islamic Republic of)