the anti-psychotic effects of adding D-penicillamine to Risperidone on positive and negative symptoms of schizophrenia
Design
randomised control trial double blind
Settings and conduct
32 hospitalized patients in Zare hospital in Sari were selected and divided into two groups of 16 cases and control group based on stratified random sampling, so that each group included equal numbers of women and men.
Participants/Inclusion and exclusion criteria
Patients with schizophrenia aged 18-65 years who have not received an anti-psychotic in last week.
Intervention groups
32 hospitalized patients were selected and divided into two groups of 16 cases and control group based on stratified random sampling, so that each group included equal numbers of women and men.
Main outcome variables
age,gender,marriage,education, PANSS score
General information
Reason for update
Acronym
Positive and Negative Symptom Scale (PANSS)
IRCT registration information
IRCT registration number:IRCT20131007014928N6
Registration date:2019-01-10, 1397/10/20
Registration timing:retrospective
Last update:2019-01-10, 1397/10/20
Update count:0
Registration date
2019-01-10, 1397/10/20
Registrant information
Name
Mehdi Pourasghar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3327 3024
Email address
m.pourasghar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Providing Placebo and medication on behalf of Mazandaran university of medical science.
Expected recruitment start date
2017-09-21, 1396/06/30
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
2017-09-21, 1396/06/30
Actual recruitment end date
2017-11-21, 1396/08/30
Trial completion date
2017-11-21, 1396/08/30
Scientific title
The investigation of the antipsychotic effects of adding d-penicillamine to risperidone on the positive and negative symptoms of schizophrenia.
Public title
The investigation of the antipsychotic effects of adding d-penicillamine to risperidone on schizophrenia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with schizophrenia that did not receive any antipsychotics during the last week.
Exclusion criteria:
Patient did not suffer from Wilson's or other metabolic diseases
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
32
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random tables
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, researchers and nurses were kept blind
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Sari-Neka road, Zare Hospital
City
sari
Province
Mazandaran
Postal code
8471674321
Approval date
2007-10-31, 1386/08/09
Ethics committee reference number
86-49
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
f20.0
ICD-10 code description
پارانویید
Primary outcomes
1
Description
Positive and negative symptoms.
Timepoint
weekly
Method of measurement
PANSS
Secondary outcomes
1
Description
Adverse effects.
Timepoint
weekly until 6 weeks.
Method of measurement
Simpson Angus Scale
Intervention groups
1
Description
16 patients in the case group were treated with oral risperidone (8-6 mg) per day for 6 weeks as a neuroleptic drug with d-penicillamine (1000 mg / day) and pyridoxine (100 mg / day).
Category
Treatment - Drugs
2
Description
Get it Sixteen patients in the control group are also given risperidone (6-8 mg daily) with pyridoxine (100 mg per os) and placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare Hospital Sari
Full name of responsible person
Dr Mehdi Pourasghar
Street address
7 km Sari Road to Neka
City
Sari
Province
Mazandaran
Postal code
4816788888
Phone
+98 11 3328 3886
Email
zarehospital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Science.
Full name of responsible person
Deputy of research and technology
Street address
Imam Square , Jouybar Road
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4800
Email
zarehospital@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Science.
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
Mazandaran University of Medical Science.
Full name of responsible person
Dr Mehdi Pourasghar
Position
Assistant Professor/Fellowship of psychotherapy
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Psychiatry and Behavioral Research Center of Mazandaran
City
Sari
Province
Mazandaran
Postal code
4816788888
Phone
+98 11 3328 6868
Fax
Email
me_pourasghar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science.
Full name of responsible person
Dr Mehdi Pourasghar
Position
Assistant Professor/Fellowship of Psychotherapy
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Psychiatry and Behavioral Research Center
City
Sari
Province
Mazandaran
Postal code
4816788888
Phone
+98 11 3328 6868
Fax
Email
me_pourasghar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mehdi Pourasghar
Position
Assisatant Professor/Fellowship of Psychotherapy
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Psychiatry and Behavioral Research Center of Mazandaran
City
Sari
Province
Mazandaran
Postal code
4816788888
Phone
+98 11 3328 6868
Fax
Email
me_pourasghar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD