Objectives: To assess the effect of Buprenorphine augmentation in regular treatment of resistant obsessive–compulsive disorder. Design: a before and after clinical trial. Setting and conduct: Eligible patients who are Patients with primary Obsessive Compulsive Disorder who received regular treatment of resistant obsessive–compulsive disorder but failed to respond to treatment and will refer to psychological clinics of Farshchian hospital during the study period will be enrolled in to the trial. Inclusion criteria: (a) Patients with primary Obsessive Compulsive Disorder who received minimum of 2 different Selective Serotonin Reuptake Inhibitor for a period of 16 weeks in two separate rotations but failed to respond to treatment (less than 25% in symptom regression); (b)age between 18 to 60 years old; (c) scores of more than 16 according to Yale-Brown Obsessive Compulsive Scale (Y-COBS)
Exclusion criteria: (a) receiving any other opioid medications; (b) having any history of alcohol or substance abuse; (c) received any electroconvulsive therapy during the last two months; (d) having any serious diseases which require long term medical treatment such as diabetes, high blood pressure, rheumatoid arthritis, cardiovascular diseases, respiratory diseases, thyroid diseases or gastrointestinal diseases; (e) any signs of psychotic disorders, such as bi-polar schizophrenia or similar; (f) being at a great risk of suicide attempt; (g) any pregnant woman or any woman who intend pregnancy during the next 3 months; (h) any serious- non psychological diseases; (i)any upcoming surgery which needs anesthesia or deep Sedation; (j) patient is a candidate to receive electroconvulsive therapy. Intervention: Tablet Buprenorphine 250 mg would be prescribed daily for 8 weeks and increased 500mg weekly with respect to patient tolerance. We will assess the Yale-Brown Obsessive Compulsive Scale before and after Buprenorphine augmentation in regular treatment using questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062422901N1
Registration date:2015-12-06, 1394/09/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-06, 1394/09/15
Registrant information
Name
Amin Reihani
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 1066
Email address
a.reihani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research of Hamadan university of medical scienses
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Buprenorphine augmentation in regular treatment of resistant obsessive compulsive disorder
Public title
Study of Buprenorphine augmentation in regular treatment of resistant obsessive compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) patients with primary Obsessive Compulsive Disorder who received minimum of 2 different Selective Serotonin Reuptake Inhibitor for a period of 16 weeks in two separate rotations but failed to respond to treatment (less than 25% in symptom regression); (b)age between 18 to 60 years old; (c) scores of more than 16 according to Yale-Brown Obsessive Compulsive Scale (Y-COBS)
Exclusion criteria: (a) receiving any other opioid medications; (b) having any history of alcohol or substance abuse; (c) received any electroconvulsive therapy during the last two months; (d) having any serious diseases which require long term medical treatment such as diabetes, high blood pressure, rheumatoid arthritis, cardiovascular diseases, respiratory diseases, thyroid diseases or gastrointestinal diseases; (e) any signs of psychotic disorders, such as bi-polar schizophrenia or similar; (f)being at a great risk of suicide attempt; (g) any pregnant woman or any woman who intend pregnancy during the next 3 months; (h) any serious- non psychological diseases; (i)any upcoming surgery which needs anesthesia or deep Sedation; (j) patient is a candidate to receive electroconvulsive therapy.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Siences
Street address
Farshchian Hospital
City
Hamadan
Postal code
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.UMSHA.REC.1394.151
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
Obsessive Compulsive Disorder severity
Timepoint
before intervention and end of 1,2,3,4,5 weeks after that
Method of measurement
Yale Brown Scale
Secondary outcomes
empty
Intervention groups
1
Description
Tablet Buprenorphine 250 mg would be prescribed daily for 8 weeks and increased 500mg weekly with respect to patient tolerance
Category
Treatment - Drugs
2
Description
The regular treatment is to start with an SSRI (Selective Serotonin Reuptake Inhibitors) or clomipramine for 4 to 6 weeks . If treatment with clomipramine or an SSRI Is unsuccessful, many therapists augment the first drug by the addition of valproate, lithium, carbamazepine, or an atypical antipsychotic such az risperidone.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Dr Ali Ghaleiha
Street address
Farshchian Hospital, Mirzade Eshghi Ave, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research of Hamadan university of medical scienses
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research of Hamadan university of medical scienses
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
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amin Reihani
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzade Eshghi Ave, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3827 1066
Fax
Email
dr.reihani.a@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University Of Medical Sciences
Full name of responsible person
Dr Ali Ghaleiha
Position
Associate Professor
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzade Eshghi Ave, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3827 1066
Fax
Email
dralighaleiha@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hmadan University of Medical Sciences
Full name of responsible person
Amin Reihani
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital, Mirzade Eshghi Ave, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3827 1066
Fax
Email
dr.reihani.a@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)