Beneficial Antipsychotic Effects of Ascorbic Acid Add-On Therapy Compared to Halloperidol Alone in Schizophrenia, (A Randomized, Double-blind, Placebo-Controlled Clinical Trial)
The aim of this study is to investigate the effect of ascorbic acid Add-On compared to Haloperidol alone in schizophrenia. A total of 50 patients with schizophrenia admitted to Zare hospital of Sari are randomly assigned into intervention or control group to receive haloperidol 15-30 mg/day plus ascorbic acid 400 mg/day or the same dose of haloperidol plus placebo for 6 weeks. Psychotic symptoms are assessed weekly by Positive and Negative Syndrome Scale for 6 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809201457N7
Registration date:2010-11-02, 1389/08/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-02, 1389/08/11
Registrant information
Name
Mehran Zarghami
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences and Department of Psychiatry, Mazandaran Univ
Country
Iran (Islamic Republic of)
Phone
+98 15 1328 5659
Email address
mzarghami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2003-04-03, 1382/01/14
Expected recruitment end date
2006-08-03, 1385/05/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Beneficial Antipsychotic Effects of Ascorbic Acid Add-On Therapy Compared to Halloperidol Alone in Schizophrenia, (A Randomized, Double-blind, Placebo-Controlled Clinical Trial)
Public title
Beneficial Antipsychotic Effects of Ascorbic Acid Add-On Therapy Compared to Halloperidol Alone in Schizophrenia, (A Randomized, Double-blind, Placebo-Controlled Clinical Trial)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: DSM-IV-TR criteria for schizophrenia, Informed consent of the patients and their tutor, living in the southern coastwise of the Caspian sea, Hospitalization in Zare Hospital
Exclusion criteria: Treatment resistance schizophrenia
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
40
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 committeee of Mazandaran University of Medical Sciences
Street address
Moallem Square
City
Sari
Postal code
4817844718
Approval date
2002-07-02, 1381/04/11
Ethics committee reference number
31-81
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Symptoms of schizophrenia
Timepoint
weekly
Method of measurement
Brief Psychiatric Rating Scale (BPRS)
Secondary outcomes
1
Description
Faster response to haloperidol and side effects
Timepoint
weekly
Method of measurement
Brief Psychiatric Rating Scale (BPRS) and clinical interview and examination
Intervention groups
1
Description
Haloperidol, 20 mg/day, orally, plus Ascorbic acid, 1500 mg/day, for 6 weeks, Biperiden (up to 6 mg/day) and lorazepam tablets were available for extra-pyramidal side effects and agitation or anxiety respectively
Category
Treatment - Drugs
2
Description
Haloperidol, 20 mg/day, orally, plus Placebo, for 6 weeks, Biperiden (up to 6 mg/day) and lorazepam tablets were available for extra-pyramidal side effects and agitation or anxiety respectively
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare Hospital
Full name of responsible person
Mehran Zarghami
Street address
Zare Hospital, Neka Road
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Jalal Hoseini Mehr
Street address
Moallem Square
City
Sari
Grant name
10506
Grant code / Reference number
31-81
Is the source of funding the same sponsor organization/entity?