This study aimed to evaluate the effect of folic acid as an adjunct in reducing the negative symptoms of hospitalized and outpatient male schizophrenia patients.
Design
A Placebo-Controlled, Double-Blind, Randomized Clinical Trial Performed on 30 Male Patients
Settings and conduct
5 Azar Gorgan Psychiatric Hospital in 2022
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Schizophrenia Diagnosis Based on V-DSM Diagnostic Criteria, Males Aged Between 18 and 50 years, No Extrapyramidal Symptoms
Exclusion Criteria: Clinically Prominent Neurological or Organic Diseases, Abnormalities in Previous Tests, Presence of Another Major I-Axis Diagnosis, 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, Long-Acting Antipsychotics in the Past Month
Intervention groups
Treated with 5 mg folic acid tablets for 6 weeks
In the control group, the drug will be used according to the previous procedure
Main outcome variables
Improving the Quality of Life and Reducing Negative Symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N55
Registration date:2022-07-09, 1401/04/18
Registration timing:prospective
Last update:2022-07-09, 1401/04/18
Update count:0
Registration date
2022-07-09, 1401/04/18
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effectiveness of Adjunctive Therapy Using Folic Acid in Reducing Negative Symptoms of Male Schizophrenia Patients
Public title
Effect of Folic Acid in Reducing Negative Symptoms of Male Schizophrenia Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Gorgan - the beginning of Shast Kola Road - Higher Education Complex of the Philosophical Deceased - Gorgan Medical School.
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2021-05-23, 1400/03/02
Ethics committee reference number
IR.GOUMS.REC.1400.044
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
5 Azar Gorgan Psychiatric Hospital
Full name of responsible person
فاطمه ضیا
Street address
5Th Azar Ave. Gorgan
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3222 0561
Email
raikaravan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mehran Hosseini
Street address
Gorgan - the beginning of Shast Kola Road - Higher Education Complex of the Philosophical Deceased - Gorgan Medical School.
City
Gorgan
Province
Golestan
Postal code
4934174515.
Phone
+98 17 3245 1653
Email
gsm@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Elahe Mehdi Zade
Position
دانشجو
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hirkan Blv., Gorgan
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3247 0110
Email
Raikaravan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Leila Kashani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hirkan Blv., Gorgan
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3247 0110
Email
Raikaravan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
الهه مهدی زاده
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hirkan Blv., Gorgan
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3247 0110
Email
Raikaravan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available