Objectives & aims: The limitations of antipsychotics for treatment of schizophrenia have led to the investigation of the usefulness of pharmacological augmentation strategies. Clinical studies have provided evidence for glutamate abnormalities in schizophrenia. Topiramate is an anticonvulsant drug with AMPA receptor antagonist properties; therefore, the objective of the present study was to explore the therapeutic efficacy of topiramate as an adjunctive medication in schizophrenia
Materials & Method: A 17 weeks, double-blind, placebo-controlled clinical trial was performed on eighty patients aged 25- to 65-year-old in 2005-2007. All were hospitalized in Mashhad psychiatric hospitals with chronic-treatment Resistant DSM-IV-TR-diagnosed schizophrenia. Up to 300 mg/day of clozapine was administered to all participants. Topiramate (200-300 mg/day) or placebo was gradually added to their ongoing treatment randomly. Efficacy of medication was measured by administering PANSS at baseline and weeks 4, 8, 12 and 17 and compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904014236N1
Registration date:2006-03-21, 1385/01/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2006-03-21, 1385/01/01
Registrant information
Name
Fatemeh Behdani
Name of organization / entity
Mashad University of Mdical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1711 2723
Email address
behdanif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
mashad university of medical sciences
Expected recruitment start date
2006-03-21, 1385/01/01
Expected recruitment end date
2007-05-22, 1386/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Topiramate augmentation compared with placebo in chronic schizophrenia admitted to Ebnesina and Hejaze Hospitals in Mashad
Public title
Effect of Topiramate in treatment of chronic schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
1. All the patients who meet the full criteria of chronic and treatment resistant schizophrenia disorder, based on DSMIV-TR
2. Ages of subjects were between 25 to 65 years
3. All patients were hospitalized for at least 6 month before the study
4. All patients were being treated with Clozapin
Exclusion criteria
1. Chronic diseases including diabetes, hypertension, history of kidney stone, epilepsy and substance abuse
2. An ongoing medical treatment
3. Elevated PANSS score up to 30%
4. Adverse effects associated with therapy including dizziness, agitation, hypertension, allergy to medications
5. Medical problems need to be treated such as diarrhea, urinary infection, cardiovascular disease, and trauma.
6. Temporary or permanent discharge from hospital while in study
7. Developing new psychiatric symptoms such as manic or hypomanic episode, panic attack
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Mashad university of medical sciences
Street address
Daneshgah Ave. Ghoreishi Building
City
Mashad
Postal code
Approval date
2006-02-05, 1384/11/16
Ethics committee reference number
1897-ت
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Positive symptoms
Timepoint
week 0, 4, 8, 12 and 17
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
2
Description
Negative Symptoms
Timepoint
week 0, 4, 8, 12 and 17
Method of measurement
Positive and Negative Syndrome Scale(PANSS)
3
Description
General Psychopathology
Timepoint
week 0, 4, 8, 12 and 17
Method of measurement
Positive and Negative Syndrome Scale(PANSS)
Secondary outcomes
1
Description
Side effects
Timepoint
week 4, 8, 12 and 17
Method of measurement
checklist
Intervention groups
1
Description
Optimum dosage of clozapine was continued for all participants for 4 weeks and then topiramate was gradually added to their ongoing treatment. Topiramate was prescribed at a dose of 50 mg on day 0. Every 2 days, the dose was increased by 50 mg/day and based on tolerability. The maximum dose allowed was 150 mg twice a day. Subjects were maintained on topiramate for 8 weeks, thereafter they were tapered and discontinued gradually in 1 week. They were followed for an additional 4 weeks on their stable antipsychotic medications.
Category
Treatment - Drugs
2
Description
Optimum dosage of clozapine was continued for all participants for 4 weeks and then placebo (was as same as topiramate in the shape and color) was gradually added to their ongoing treatment. Subjects were maintained on placebo for 8 weeks, thereafter they were tapered and discontinued gradually in 1 week. They were followed for an additional 4 weeks on their stable antipsychotic medications.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebnesina Hospital
Full name of responsible person
Fatemeh Behdani
Street address
Horre Amel Bulevard
City
Mashad
2
Recruitment center
Name of recruitment center
Hejaze Hospital
Full name of responsible person
Fatemeh Behdani
Street address
Khajeh Rabei
City
Mashad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashad university of medical sciences
Full name of responsible person
Dr Monavar Afzalagae
Street address
Daneshgah Ave., Goraishi Buillding, vice chancellor for research
City
Mashad
Grant name
0000
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashad university of medical sciences
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
Mashad University of Medical Sciences
Full name of responsible person
Fatemeh Behdani
Position
Psychiatrist, Associate Professor
Other areas of specialty/work
Street address
Ebne Sina Hospital
City
Mashad
Postal code
Phone
+98 51 1604 3772
Fax
Email
behdanif@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashad University of Medical Sciences
Full name of responsible person
Paria Hebrani
Position
Associate Professor, Psychiatrist
Other areas of specialty/work
Street address
Horre Ameli Ave., Ebne Sina Hosphtal
City
Mashad
Postal code
Phone
+98 51 1761 6158
Fax
Email
اhebranip@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)