The effect of adding pyridostigmine to second generation antipsychotic drugs on schizophrenia symptoms: A double blind randomised placebo controlled clinical trial
In this clinical trial research we select random 30 schizophrenic patients 20-40 years old in psychiatric ward of Golestan hospital that are treated with 2 generation antipsychotic drugs .The main goal of research is checking the effect of adding pyridostigmine with 2 generation antipsychotics on schizophrenia symptoms. after explain about research to patients and their families and filling consent form and with regard to inclusion and exclusion criteria will devide to 2 groups : experimental and placebo groups.we add pyridostigmin tablet 60 mg with experimental group once a day and placebo tablet with control group once a day too.the time of research is 4 weeks.It should be noted that placebo is very similar to pyridostigmine tablets in shape, size, color.we use BPRS and PANSS scales at the begining and end of research.PANSS scale measure the positive and negative symptomes of schizophrenia and other psychoyic disorders and it has become to the standard tool to evaluate the clinical outcome of schizophrenia studies.BPRS is brief scale is used to measure psychiatric symptoms.
This scale from a few decades ago is used to assess the outcome of the schizophrenia treatment studies and it is usefull for patients with signalize destruction.
the main inclusion criteria is having schizophrenia disorder.inclusion criteria : the average age between 20 to 40 years and knowing persian language and having consent of participation in this research and having no brain organic disease and using no any anti depressant such as tricyclics drugs and donepezil drug.
exclusion criteria :demensia and severe organic disease and Non-compliance patients and very old age and young age and other neurologic diseases that patients must use anticholinesetrase drugs and use of tricyclics antidepressants and donepezi drug.
positive symptoms of schizophrenia such as hallucination,dellusion and etc ,negative symptoms such as abulia and anhedonia and etc,cognitive symptoms such as memory ,attension and etc and agitation and anxiety and depression and duration of hospitalization are main outcome variables.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041521779N1
Registration date:2015-10-28, 1394/08/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-28, 1394/08/06
Registrant information
Name
Rokhshid Pirboveri
Name of organization / entity
Jondi Shapour university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 1179
Email address
pirboveyri.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Jondi Shapour university of medical sciences of Ahvaz
Expected recruitment start date
2015-06-01, 1394/03/11
Expected recruitment end date
2016-06-01, 1395/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding pyridostigmine to second generation antipsychotic drugs on schizophrenia symptoms: A double blind randomised placebo controlled clinical trial
Public title
The effect of adding pyridostigmine to second generation antipsychotic drugs on schizophrenia symptoms: A double blind randomised placebo controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
The main inclusion criteria is having schizophrenia disorder.inclusion criteria: The average age between 20 to 40 years and knowing persian language and having consent of participation in this research and having no brain organic disease and using no any anti depressants such as tricyclics drugs and donepezi drug.
Exclusion criteria :demensia and severe organic disease and very old age and young age and other neurologic diseases that patients must use anticholinesterase drugs and use of tricyclic antidepressants and donepezil drug.
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committy of Jondi Shapour University of Medical Sciences of Ahvaz
Street address
Golestan Street، Ahvaz ، Khouzestan
City
Ahvaz
Postal code
6135874366
Approval date
2015-01-31, 1393/11/11
Ethics committee reference number
13930401
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
f20
ICD-10 code description
The schizophrenic disorders are characterized in general by fundamental and characteristic distortions of thinking and perception, and affects that are inappropriate or blunted. Clear consciousness and intellectual capacity are usually maintained although
Primary outcomes
1
Description
Schizophrenic Disorder Symptom
Timepoint
In First And End Of 4 Weeks Of Research
Method of measurement
By Using Panss And Bprs Scales
Secondary outcomes
1
Description
Comparsion between complications of adding pyridostigmine with 2 generation antipsycotic drugs versus complications of antipsychotics alone
Timepoint
Along of research
Method of measurement
With recurrent visit of patients.
Intervention groups
1
Description
Interventional group:this group that include 15 schizophrenic patients are selected quite rondom and treated with 2 generation antipsychotic drugs , pyridostigmine tablet 60 mg will add to main treatment daily for one month.It is worth mentioning that pyridostigmine is one of anticholinestrase drugs and one of common treatment of MYASTHENIA GRAVIS disease. At the begining and end of 4 weeks
we check PANSS and BPRS for paitients.
Category
Treatment - Drugs
2
Description
In placebo group that include 15 schizophrenic patients are selected rondom and treated with 2 generation antipsychotic drugs, placebo tablet that is quite similar to pyridostigmine tablet will add to their main treatment for one months.At begining and end of 4 weeks , PANSS and BPRS scales will check for patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital of Ahvaz
Full name of responsible person
Dr Boostani Haatam, Asistant Professor of Psychiatry of Jondi Shapour University of Medical Sciences
Street address
Golestan Hospital، Golestan Street، Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Jondi Shapour University Of Medical Sciences of Ahvaz
Full name of responsible person
Dr Saaki Naader
Street address
Jondi Shapour University Of Medical Sciences of Ahvaz,Golestan Street, Ahvaz, Khouzestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Jondi Shapour University Of Medical Sciences of Ahvaz
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Jondi Shapour University of Medical Sciences of Ahvaz
Full name of responsible person
Dr Pakseresht Syrous
Position
Asistant Professor of Psychiatry in Jondi Shapour University of Medical Sciences of Ahvaz