Assessing the effectiveness of treatment by aripiprazole and placebo with lithium and benzodiazepin to control of obsesion in patients with Bipolar mood disorder
Study design: Interventional clinical trial and double blind.
The purpose of the study: compared the effect of aripiprazole with placebo on the obsessive-compulsive symptoms in patients with bipolar mood disorder.
Common treatment for this disorder contain mood stabilization preferably Lithium plus Antipsychotic and Benzodiazepines. Obsessive Compulsive Disorder (OCD) is the most common comorbidities associated with bipolar disorder that can worsen prognosis and increase risk of suicide. Selective Serotonin Reuptake Inhibitor and Tricyclic antidepressant are common treatment of OCD but this drugs with probability of shift to mania. Aripiprazole is effective on mania and mixed episode and also relapse prevention.
Main inclusion and exclusion criteria: is Yale Brown Score more than 16 at baseline.
Population: Patients that referred to Shiraz University of Medical Science clinics are target.
Target size: is 40, 20 patients in each group (A and B).
Intervention: Aripiprazole start with initial dose of 5 milligram/day and 5 milligram added every week till reach up to 20 mg daily. One group receive Aripiprazole in addition to Lithium and Benzodiazepine and another receive placebo in addition to Lithium and Benzodiazepine.
Variable: Obsession severity assessment done at week 0, 4th and 8th. Side effects will be evaluated according to the side effects list at weeks 4 and 8.
General information
Acronym
Research center for Psychiatry and Behavior Science
IRCT registration information
IRCT registration number:IRCT2014092719295N1
Registration date:2017-03-07, 1395/12/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-07, 1395/12/17
Registrant information
Name
Ali Sahraian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 9319
Email address
sahraian@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research Shiraz University of Medical Sciences
Expected recruitment start date
2016-05-14, 1395/02/25
Expected recruitment end date
2017-03-15, 1395/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effectiveness of treatment by aripiprazole and placebo with lithium and benzodiazepin to control of obsesion in patients with Bipolar mood disorder
Public title
Assessing the effectiveness of treatment by aripiprazole and placebo for control of obsesion in patients with Bipolar mood disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with a diagnosis of bipolar disorder according to the DSM IV TR criteria; Yale Brown Score more than 16 at baseline; No important medical condition
Exclusion criteria: Patients were not in acute phase of depression and mania; Important medical condition (cardiovascular, Respirator, renal, Gastrointestinal disease); Pregnancy; Yale Brown Score less than 16 at baseline
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
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
Shiraz University of Medical Sciences
Street address
zand avenue, medical school
City
Shiraz
Postal code
Approval date
2016-05-14, 1395/02/25
Ethics committee reference number
IR.SUMS.MED.REC.1395.16
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder
2
Description of health condition studied
Obsessive-Compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Obsession severity
Timepoint
Weeks 0 and 4 and 8
Method of measurement
Yale Brown Test (Y-BOCS)
Secondary outcomes
1
Description
Side edffect
Timepoint
Weeks 4 and 8
Method of measurement
Side effect list
Intervention groups
1
Description
The study is a double blind clinical trial. Interventional Group (Group A) is 20 people that receive Aripiprazole in addition to Lithium and Benzodiazepine (if necessary). Administrator is doing Obsession severity assessment at week 0 by Yale Brown questionnaire and main partner do follow in next weeks. Side effects will be evaluated according to the side effects list at weeks 4 and 8. Change in symptoms of obsession also evaluated at weeks 4 and 8. Administrator is present every tuesday to visit patients at the clinic and give number to patient if necessary. Lithium and Benzodiazepine dose prescribed at a level which will control symptoms. Aripiperazol start with initial dose of 5 milligram/day and 5 milligram added every week till reach up to 20 mg daily (Base on tolerance drugs be adjusted). Yale Brown questionnaire has 10 items and each item receives a score of 0 to 4 (no symptoms to maximum). Questions are about time for washing, create problems in life, patient resistance and control on thoughts and rituals. The same questions ask about compulsions. The questionnaire had Validity and reliability in various studies.
Category
Treatment - Drugs
2
Description
This study is a double blind clinical trial. Control Group (Group B) is 20 people that receive Placebo in addition to Lithium and Benzodiazepine (if necessary). Administrator is doing obsession severity assessment at week 0 by Yale Brown questionnaire and main partner do follow in next weeks. Side effects will be evaluated according to the side effects list at weeks 4 and 8. Change in symptoms of obsession also evaluated at weeks 4 and 8. Administrator is present every tuesday to visit patients at the clinic and give number to patient if necessary. Lithium and Benzodiazepine dose prescribed at a level which will control symptoms (drugs Will be adjusted based on patient tolerance). Placebo administered with the same dose of Arippiperazol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Zahra Ehsaei
Street address
Zand avenue
City
Shiraz
2
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Zahra Ehsaei
Street address
Chamran avenue
City
Shiraz
3
Recruitment center
Name of recruitment center
Ebnsina Hospital
Full name of responsible person
Zahra Ehsaei
Street address
Hafezie avenue
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for Research Shiraz University of Medical Sciences
Full name of responsible person
Ebrahim Moghimi
Street address
Zand street, Shiraz University of Medical Sciences
City
Shiraz,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for Research Shiraz 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
Department of Psychiatry, Siraz University of Medical Sciences
Full name of responsible person
Zahra Ehsaei
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Hafez Hospital, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 3627 9319
Fax
Email
Zahraehsaei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Psychiatry department, Siraz University of Medical Sciences
Full name of responsible person
Ali Sahraian
Position
Psychiatrist, Professor
Other areas of specialty/work
Street address
Department of Psychiatry, Hafez Hospital ,Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 3627 9319
Fax
Email
Sahraian@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Psychiatry Research Center,
Full name of responsible person
Zahra Ehsaei
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Department of Psychiatry, Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 3627 3070
Fax
Email
Zahraehsaei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)