ٍEvaluation of therapeutic efficacy of treatment with olanzapine and halopridol on regional cerebral blood flow measured by SPECT in patients with schizophrenia, correlating with the response to treatment
The aim of this study is to evaluate the rCBF of the schizophrenic patients treated with olanzapine and halopridole in a within-subject and between-subject design. Thirty patients with schizophrenia are participating in the study. Each subject will be scanned and assessed according to PANSS and CGI in a medication-free state. All patients are randomly allocated in two groups. One group is being treated with fixed dose of 15 mg/day olanzapine and the other with 10 mg halopridole. All assessments will be repeated after 4 weeks of treatment. Also a group of 12 cases without any history of neurological or psychological disorder are enrolled as a control group for comparing of the SPECT data. The changes in pattern of regional perfusion will be evaluated between control and two groups of patient subjects and also in each patients group before and after treatment. The correlation between clinical improvement and rCBF changes in each groups after treatment will also be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706051100N1
Registration date:2011-08-16, 1390/05/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-16, 1390/05/25
Registrant information
Name
Davood Beiki
Name of organization / entity
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 3333
Email address
beikidav@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2007-01-10, 1385/10/20
Expected recruitment end date
2008-11-11, 1387/08/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ٍEvaluation of therapeutic efficacy of treatment with olanzapine and halopridol on regional cerebral blood flow measured by SPECT in patients with schizophrenia, correlating with the response to treatment
Public title
Treatment of schizophrenia with antipsychotic drugs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the criteria of DSM-IV for schizopherenia; neuroleptic drug-naive or drug-free for at least 4 weeks; age range from 18-58 years; filling consent form; no drug tranqulization for at least five half life of the drug; no psychoactive drug therapy for at least 5 half life of the drug. Exclusion criteria: Accompanied disorders of axis 1 or 2 based on DSM-IV; evidence of neurological disease; History of any drug abuse; elevating hepatic enzymes; pregnancy; thyroid dysfunction; consumption of drugs interferring with HT25 or D2 receptors.
Age
From 18 years old to 58 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz boulevard
City
Tehran
Postal code
-
Approval date
2006-11-14, 1385/08/23
Ethics committee reference number
85-02-30-3805
Health conditions studied
1
Description of health condition studied
Schizopherenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
alteration in cerebral perfusion
Timepoint
one month after using the drug
Method of measurement
cerebral perfusion scan
Secondary outcomes
1
Description
Changes in severity of clinical symptoms
Timepoint
one month after onset of the treatment
Method of measurement
PANSS and CGI tests for clinical symptom score
Intervention groups
1
Description
Olanzapine 10 mg/da
Category
Treatment - Drugs
2
Description
Haloperidole 10 mg/day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Institute for Nuclear Medicine and Roozbeh Hospital, Tehran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Keshavarz boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Tehran 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
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Babak Fallahi
Position
Associate Professor of Nuclear Medicine
Other areas of specialty/work
Street address
Shariati Hospital, N Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 8863 3333
Fax
+98 21 8802 6905
Email
bfallahi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Babak Fallahi
Position
Associate Professor of Nuclear Medicine
Other areas of specialty/work
Street address
Shariati Hospital, N Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 8863 3334
Fax
+98 21 8802 6905
Email
bfallahi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Davood Beiki
Position
Associate Professor of Nuclear Pharmacy
Other areas of specialty/work
Street address
Shariati Hospital, N Kargar Ave.
City
Tehran
Postal code
Phone
Fax
Email
beikidav@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)