The object of this randomized,double blind clinical trial is to test the hypothesis that the addition of Aripiprazole to Litium would more effective in control of psychotic symptom in bipolar patient then Risperidon. 60 patient with ages more than 18 years who have no other medical or psychiatric conditions with DSM-IV-TR diagnosed psychotic bipolar in manic phase will receive Litium combined with either Aripiprazole (N=30) or Risperidon(N=30) for 3 week. Efficacy will be defined as the change from baseline to endpoint in score on the Young mania Rating scale(YMRS).Side effects will be also evaluated using SAS,AIMS,BARS.YMRS,BPRS will be evaluated at baseline ,7,14 and 21 days.
General information
Acronym
ALD
IRCT registration information
IRCT registration number:IRCT201409176691N2
Registration date:2015-01-27, 1393/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-27, 1393/11/07
Registrant information
Name
Fatemeh Sheikhmoonesi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1328 5109
Email address
fmoonesi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences and Health Service
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
COMPARISION THE EFFICACY OF ADJUCTIVE THERAPY RISPERIDON OR ARIPIPERAZOL TO LITIUM IN BIPOLAR DISORDER(MANIC PHAZE WITH PSYCHTIC FEATHER)
Public title
effect of aripiperazole in treatment of psychotic mania
Purpose
Treatment
Inclusion/Exclusion criteria
criteria: Age more than 18 years; Diagnosis of Bipolar disorder with psychotic symptom based on DSM-IV TR; Ongoing treatment with Litium as a mood stabilazor with seromic level between 0.8-1.2meq/L ; patient with YMRA>20.Exclusion criteria: Mental Retardation; Pregnancy or Breast Inclusion feeding;Any chronic medical problem; substance abuse; Any other psychiatric Disorder in Axis I OR II;Allergic to Aripiprazole and other Atypical Antipsychotic drug ;History of epileptic disorder; Delirium state.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Mazandaran University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Building N.2, Moallem Square, Moallem Street Sari
City
sari
Postal code
4815466848
Approval date
2014-03-05, 1392/12/14
Ethics committee reference number
92-178
Health conditions studied
1
Description of health condition studied
mania
ICD-10 code
F31
ICD-10 code description
bipolar affective disorder
2
Description of health condition studied
bipolar disorder
ICD-10 code
F31
ICD-10 code description
bipolar affective disorder
Primary outcomes
1
Description
Severity of manic phase and psychotic symptom
Timepoint
Baseline and days 7-14-21 after beginig of treatment
Method of measurement
YMRS
Secondary outcomes
1
Description
Akatezia
Timepoint
days 2-4-7-10 after beginig of treatment then every weeks
Method of measurement
BARS
2
Description
extrapyramidal
Timepoint
days 2-4-7-10 after beginig of treatment then every weeks
Method of measurement
AIMS
3
Description
diskinesia
Timepoint
days 2-4-7-10 after beginig of treatment then every weeks
Method of measurement
SAS
Intervention groups
1
Description
Litium combined with Tabiet Aripiprazole(30 mg/day) as intervention group for 3 weeks.
Category
Treatment - Drugs
2
Description
Litium combined with Tablets Risperidon(6mg/day) as control group for 3weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare Psychiatry Hospital
Full name of responsible person
Dr Fatemeh Sheikhmoonesi
Street address
Psychiatric Department, Zare Psychiatry Hospital, Sari
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayati
Street address
Vice Chancellor for Research and Technology, Building N.2, Moallem Square, Moallem Street
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Sheikhmoonesi
Position
Assistant Prof. of Psychiatry, Psychiatrist
Other areas of specialty/work
Street address
Zare Psychiatry Hospital
City
Sari
Postal code
4815466848
Phone
+98 11 3326 1245
Fax
+98 11 3328 5109
Email
fmoonesi@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Sheikhmoonesi
Position
Assistant Prof. of Psychiatry,Psychiatrist
Other areas of specialty/work
Street address
Zare Psychiatry Hospital
City
Sari
Postal code
4815466848
Phone
+98 11 3326 1245
Fax
+98 11 3328 5109
Email
fmoonesi@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Fatemeh Sheikhmoonesi
Position
Assistant Prof. of Psychiatry, Psychiatrist
Other areas of specialty/work
Street address
Zare Psychiatry Hospital
City
Sari
Postal code
4815466848
Phone
+98 11 3326 1245
Fax
+98 11 3328 5109
Email
fmoonesi@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)