This study will assess the efficacy and safety of tamoxifen as an adjunctive agent to lithium and risperidonel for the treatment of acute mania in hospitalized bipolar patients. Methods: patients aged between 18 and 49 wil be eligible to participate, as they met theDSM-IV criteria for a current manic episode, on the basis of a clinical interview by two academician psychiatrists. In addition, a score of at least 20 points on the Young Mania Rating Scale will be required representing at least a moderate-to-severe mania. Exclusion: Other diagnosis in Axis 1, substance dependence, severe medical problems and lactating and pregnant women.
Patients will be randomly allocated to lithium (1–1.2 mEq/L) + risperidone + tamoxifen (80 mg/day) (group A) or lithium (1–1.2
mEq/L) + risperidone + placebo (group B) for an 6-week, double-blind, placebo-controlled study. Patients were assessed by a third year resident of psychiatry at baseline and at 7, 14, 28, 42,days after the medication started. The mean decrease in the Young Mania Rating Scale score from baseline will be used as the main outcome measure of response of mania to treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT1138901151556N12
Registration date:2010-04-29, 1389/02/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-04-29, 1389/02/09
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical sciences
Expected recruitment start date
2010-03-01, 1388/12/10
Expected recruitment end date
2010-05-01, 1389/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double - blind placebo controlled traial of tamoxifen added to litihium in patint with acute mania
Public title
tamoxifen added to litihium in patint with acute mania
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged between 18 and 49 wioll be eligible to participate, as they meet the DSM-IV criteria for a current manic episode, on the basis of a clinical interview by two academician psychiatrists. In addition, a score of at least 20 points on the YoungMania Rating Scale will be required representing at least a moderate-to-severe mania.
Exclusion criteria: Other diagnosis in Axix 1, substance dependence, severe medical problems and lactating and pregnant women.
Age
From 18 years old to 49 years old
Gender
Both
Phase
2
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
Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2009-05-12, 1388/02/22
Ethics committee reference number
6965
Health conditions studied
1
Description of health condition studied
Mania episode
ICD-10 code
F30
ICD-10 code description
Mania episode
Primary outcomes
1
Description
Score of Young Mania Rating Scale
Timepoint
evey two weeks from the begining of trial till week 8
Method of measurement
by Young Mania Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervension: Risperidone tablet(4 mg/day) combined with tamoxifen tablet (80 mg/day) + lithium tablet 1800mg/day as intervention group for 6 weeks
Category
Treatment - Drugs
2
Description
Control group: Risperidone tablet (4 mg/day) combined with placebo tablet + lithium tablet 1800mg/day as control group for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
Roozbeh Hospital
City
Tehran
2
Recruitment center
Name of recruitment center
Department of Psychiatry
Full name of responsible person
Dr. Bahman Salehi
Street address
Arak University of Medical Sciences
City
Arak
3
Recruitment center
Name of recruitment center
Department of Psychiatry
Full name of responsible person
Dr. Farzin Rezaei
Street address
Kordistan University of Medical Sciences
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Keshavarz Blvd
City
Tehran
Grant name
6965
Grant code / Reference number
6965
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Ph.D.
Other areas of specialty/work
Street address
Roozbeh Hospital
City
Tehran
Postal code
Phone
+92 1554 12222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
ph.D.
Other areas of specialty/work
Street address
Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)