The comparison of Aripiprazole and Quetiapine augmentation between Selective Serotonin reuptake inhibitors in refractory obsessive-compulsive disorder.
The aim of the study is to investigate the comparative efficacy and tolerability of Aripiprazole versus Quetiapine over a period of 12 weeks. Inclusion criteria: Age between 18-65 years: Patients with a diagnosis of OCD. The exclusion criteria: Patients with current or previous diagnosis of psychosis. 30 patients, who are selected from psychiatry clinic in Ibn-e-Sina hospital. Patients are divided to 2 groups of A and B. In group A, aripiprazole will be given to patients as an augmentation therapy with initial dose of 5 mg/day. Then according to the patient's symptoms and tolerance, the dose will be increased up to 20 mg/day over a course of 12 weeks. In group B, patients will be treated with quetiapine with an initial dose of 50 mg/day and gradually, the dosage will be increased up to 300 mg/day. During the trial SSRI drug will be continued with maximum dose. All patients will be assessed by psychiatrist at the beginning of medication and at 4th, 8th and 12th week of treatment and at the beginning of the study and at the end of week 4, 8 and 12 Yale-Brown Obsessive-Compulsive scales (Y-BOCS), Clinical Global Impression-Severity scale (CGI-S) tests and at the beginning of the study and at the end of week 12 Hamilton Rating Scale for Depression (HDRS) test will be done. The results of the medical tests will be reviewed based on score drop testes of Y-BOCS and CGI-S.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013040612905N1
Registration date:2014-01-11, 1392/10/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-11, 1392/10/21
Registrant information
Name
zahra Aghili
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1842 4808
Email address
aghiliz891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Aripiprazole and Quetiapine augmentation between Selective Serotonin reuptake inhibitors in refractory obsessive-compulsive disorder.
Public title
The comparison of Aripiprazole and Quetiapine augmentation between Selective Serotonin reuptake inhibitors in refractory obsessive-compulsive disorder.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Age between 18-65 years؛Patients with a diagnosis of OCD؛Patients who are non-responsive to primary treatment confirmed by a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score more than 16.
The exclusion criteria:Patients with current or previous diagnosis of psychosis؛ Mental retardation؛Substance abuse؛ Psychiatric disorders due to organic diseases.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah Street.
City
Mashhad
Postal code
Approval date
2012-10-20, 1391/07/29
Ethics committee reference number
910023
Health conditions studied
1
Description of health condition studied
obsessive- compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
obsession sevirity
Timepoint
before intervention\ week4\week8\ week12
Method of measurement
score of Y-BOCS test
2
Description
general improvement
Timepoint
before intervention\ week 4\ week 8\ week12
Method of measurement
score of CGI test
3
Description
depression
Timepoint
before intervention\ week 12
Method of measurement
Hamilton Depression Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Adding Aripiprazole 5 to 20 mg per day/ Qd. in period of 12 week depend on a tolerance of the patient with the brand name: Abilizole.
Category
Treatment - Drugs
2
Description
Adding quetiapine100 to 200 mg per day/ Qd. in period of 12 week depend on a tolerance of the patient with the brand name: Tranqupine al Sciences obsession degree.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Outpatient clinic of Ibnesina's hospital
Full name of responsible person
Dr zahra Aghili. Resident of psychiatry
Street address
Ibn-e-sina Hospital.Horeameli Ave. Boali Sq.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Ardakanian Marjan
Street address
Ghoreish building, Daneshgah St.
City
Mashad
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, 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 zahra Aghili
Position
resident
Other areas of specialty/work
Street address
Ibn-e-sina hospital, Hore ameli blv.
City
Mashhad
Postal code
Phone
+98 51 1711 2721
Fax
Email
zahra.Aghili@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Ali Talaee
Position
Associate Professor
Other areas of specialty/work
Street address
Ibn-E- Sina Hospital
City
Mashhad
Postal code
Phone
+98 51 1711 2540
Fax
Email
TalaeiA@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 zahra Aghili
Position
MD
Other areas of specialty/work
Street address
Ibn-e-sina Hospital, Hore ameli blv.
City
Mashhad
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)