The psychotic women with good response to risperidone that the change to clozapine isn’t possible, entered to study. The aim of this study is treatment of risperidone induced hyperprolactinemia.
The main criterias of inclusion to study are women in reproductive age and hyperprolactinemia and criterias of exclusion are previous amenorrhea, breastfeeding, pregnancy and past history of seizure …. In these patients, the serum prolactine is measured in initial phase of study and monthly for three months. in prolactine levels of greater than 200 mg/dl or appearance of hyperprolactinemia symptoms and signs , aripiprazole is added on risperidone. Then serum prolactine level is meseaured weekly for 2 weeks and monthly for 3 months. Anti psychotic side effects such as weight are determined before initiation of aripiprazole and then monthly for three months. The primary sample size of this study are 40 patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307182181N6
Registration date:2013-07-28, 1392/05/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-28, 1392/05/06
Registrant information
Name
Fatemeh Ranjbar Kouchaksaraei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 6923
Email address
ranjbarf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
research deputy
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Adjunctive treatment with Aripiprazole for Risperidone –induced hyperprolactinemia
Public title
Adjunctive treatment with Aripiprazole for Risperidone –induced hyperprolactinemia
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criterias :
1.hyperprolactinemia
2. women in reproductive age
3.candidate for risperidone continuation
exclusion criterias:
1.previous amenorrhea
2.breastfeeding
3.pregnancy
4.renal failure
5. hypothyroidism
6. pituitary tumors
7. consumption of methyldopa, levodopa,cimethidine, strogen, opium derivatives
Age
From 20 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research deputy
Street address
golgasht Ave.
City
tabriz
Postal code
Approval date
2012-11-21, 1391/09/01
Ethics committee reference number
5/4/7828
Health conditions studied
1
Description of health condition studied
hyperprolactinemia induced by risperidone
ICD-10 code
E22.1
ICD-10 code description
Hyperprolactinaemia
Primary outcomes
1
Description
serum prolactin level
Timepoint
weekly for first 2 weeks then monthly for 3 months
Method of measurement
mg/dl
Secondary outcomes
1
Description
drug side effect
Timepoint
the end of study
Method of measurement
patient interview
Intervention groups
1
Description
aripiprazole is added on risperidone if :
1. serum prolactine > 200 mg/dl or
2.appearing any symptoms or signs of hyperprolactinemia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
razi hospital
Full name of responsible person
dr fatemeh ranjbar kouchaksaraei
Street address
elgoli Ave.
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
tabriz university of medical science
Full name of responsible person
research deputy
Street address
golgasht Ave
City
tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
tabriz university of medical science
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
razi hospital
Full name of responsible person
Fatemeh Ranjbar Kouchaksaraei
Position
associate professor
Other areas of specialty/work
Street address
elgoli Ave
City
tabriz
Postal code
Phone
+98 41 1380 3353
Fax
Email
fk_ranjbar@yahoo.comranjbarf@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
tabriz university of medical sceinces
Full name of responsible person
Fatemeh Ranjbar Kouchaksaraei
Position
associate professor
Other areas of specialty/work
Street address
elgoli Ave
City
tabriz
Postal code
Phone
+98 41 1380 3353
Fax
Email
fk_ranjbar@yahoo.comranjbarf@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
razi hospital
Full name of responsible person
parisa niari khams
Position
psychiatry resident
Other areas of specialty/work
Street address
elgoli Ave
City
tabriz
Postal code
Phone
+98 41 1380 3353
Fax
Email
parisa7989@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)