There are not appropriate responses for monothrapyinprepubertalor early onset bipolar disorder and afew controlled trials exist for combind therapy in them.some study have been conducted about the role of tamoxifen in the treatment of bipolar disorderinadults.this study is designed to investigate the efficacy AND tolerability of combindtamoxifen and lithium treatment in youths (10-20Years old)with acute mania in hospitalized bipolar patients.This is arandomized placebo _controlled clinical trial in 2013-2014 in an 3week.44adolescnts with diagnosis of bipolar disorder is randomized for treatment with lithium plus tamoxifen(n=22)or lithium plus placebo(n=22).In addition ascore of atleast 20points of the young mania rating scale are requiredand and known sensivity to tamoxifen or lithium is the exclusion criteria.The primary outcome measure is young mania rAting scale and child depression inventory scale.the serum level of lithium and side effects evaluate weekly ,and Reduction in Young Mania score of less than 50% of the initial value is considered as a therapeutic response.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410126418N3
Registration date:2015-02-27, 1393/12/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-27, 1393/12/08
Registrant information
Name
Soroor Arman
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 313 2535
Email address
arman@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of efficacy of lithium and tamoxifen in the treatment of acute mania in bipolar affective disorder.
Public title
Tamoxifen Effects in Acute mania in Youth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria Consistent 9-22 years old with current manic episode (with or without psychotic feature) as diagnosed by means of the structured clinical interview for Axis I DSM-IV disorders-Patient version (SCDI-P).A score of at least 20 points on the Young Mania Rating Scale was required representing at least a moderate-to- severe mania.
Exclushon Criteria: Neurological or other medical impairement- The need for ongoing treatment with other psychoactive medications and/or current substance dependence- Mental Retardation (IQ<70)- History of renal or liver function impairements- History of coagulopathy,
Age
From 9 years old to 22 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
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
Medicin college of Isfahan University of Medical Sciences
Street address
Hezar Jarib St.-Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2014-09-17, 1393/06/26
Ethics committee reference number
393501
Health conditions studied
1
Description of health condition studied
mania in youth
ICD-10 code
F31.1-F31.
ICD-10 code description
A disorder characterized by two or more episodes in which the patient's mood and activity levels are significantly disturbed, this disturbance consisting on some occasions of an elevation of mood and increased energy and activity (hypomania or mania) and
Primary outcomes
1
Description
Young Mania Rating Scale
Timepoint
First Week-Second Week-Third Week
Method of measurement
Questionair
Secondary outcomes
1
Description
Child Depression Rating Scale
Timepoint
First Week-Second Week- Third Week
Method of measurement
Questionair
Intervention groups
1
Description
intervention goup are randomly allocates in to lithium (1-1/2meq/lit)+tamoxifen(40mg/day)(Group A)for a3weeks.The principle measures of outcomeare the Young Mania Rating Scale and Child Depresion Inventory scale,and measure evaluate weekly.
Category
Treatment - Drugs
2
Description
Control goup are randomly allocates into lithium (1-1/2meq/lit)+placebo(Group B)for a3weeks.The principle measures of outcomeare the Young Mania Rating Scale and Child Depresion Inventory scale,and measure evaluate weekly.