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Effect of bupropion on cognitive function in schizophrenia

Protocol summary

Summary
The objective of this study was to assess the effects of bupropion on cognitive function in schizophrenia This study is a double blind case – control study in a large referral psychiatric university hospital in Iran (Mashhad) from June 2013 until September 2014 . Inclusion criteria were a DSM-IV-TR diagnosis of schizophrenia, smoking at least 10 cigarettes a day.exclusion criteria were major depressive, manic, or hypomanic episode, and seizure disorder and having contraindications for use of bupropion. Nightheen smoker schizophrenic patients were randomly allocated in two groups for 4 weeks (46 patients in cases and 44 patients in control group) . They get antipsychotic Risperidone2 mg during smoking cessation they get 100 mg bupropion in second week 200 mg per day, and control group placebo. Positive And Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14th and 28th day of study. Cognitive tests (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, 2nd, 7th, 14th, 28th of study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201509055280N20
Registration date: 2015-10-24, 1394/08/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-24, 1394/08/02
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2011-04-04, 1390/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of bupropion on cognitive function in schizophrenia
Public title
Effect of bupropion on cognitive function in schizophrenia: A double-blind placebo and controlled study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were a DSM-IV-TR diagnosis of schizophrenia, smoking at least 10 cigarettes a day.exclusion criteria were major depressive, manic, or hypomanic episode, and seizure disorder. And having contraindications for use of bupropion.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random based on random numbers table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical sciences
Street address
Ghoraishy Building, University St.
City
Mashhad
Postal code
Approval date
2009-01-28, 1387/11/09
Ethics committee reference number
87348

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
Psychotic and anti-psychotic symptoms assessment
Timepoint
beginning of study, 14th and 28th day of study
Method of measurement
Brief psychiatric rating scale (BPRS)

2

Description
Positive and Negative Symptoms Scale
Timepoint
beginning of study, 14th and 28th day of study
Method of measurement
Positive and Negative Symptoms Scale (PANSS)

3

Description
Memory
Timepoint
in begging of study, 2nd, 7th, 14th, 28th of study
Method of measurement
( WMS ) Wechsler Memory Scale

4

Description
Executive functions
Timepoint
in begging of study, 2nd, 7th, 14th, 28th of study
Method of measurement
(WCST) Wisconsin Card Sorting Test

5

Description
Selective attention and cognitive flexibility
Timepoint
in begging of study, 2nd, 7th, 14th, 28th of study
Method of measurement
Stroop test

6

Description
Memory
Timepoint
in begging of study, 2nd, 7th, 14th, 28th of study
Method of measurement
Digit Span

Secondary outcomes

empty

Intervention groups

1

Description
Both of group get antipsychotic Risperidone2-6 mg/day( Dr Abidi pharma) and placebo group received a similar placebo tablet daily..
Category
Treatment - Drugs

2

Description
Both of group get antipsychotic Risperidone2-6 mg/day and intervention group were received bupropion 100-200mg/day( Dr Abidi pharma).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn e Sina Hospital
Full name of responsible person
Dr Mansoureh Mirzadeh
Street address
Ibn-e-Sina Hospital, Bu-Ali Sq., Amel Blvd., Mashhad,Iran.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr Mahyar Mirheydari
Street address
Ghoraishy Building, University St.
City
Mashhad
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 Mashhad 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
Mashhad University of Medical sciences
Full name of responsible person
Dr Najmeh Shahini
Position
Resident
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital, Bu-Ali Sq., Amel Blvd., Mashhad,Iran.
City
Mashhad
Postal code
Phone
+98 51 3711 2701
Fax
Email
ShahiniN921@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical sciences
Full name of responsible person
Dr Mansoureh Miradeh
Position
Psychiatrist
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital, Bu-Ali Sq., Amel Blvd., Mashhad,Iran.
City
Mashhad
Postal code
Phone
+98 51 3711 2701
Fax
Email
mirzadehm@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Najmeh Shahini
Position
Resident
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital, Bu-Ali Sq., Amel Blvd., Mashhad,Iran.
City
Mashhad
Postal code
Phone
+98 51 3711 2701
Fax
Email
ShahiniN921@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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