The efficacy of augment of D-Cycloserine and cognitive-behavioral therapy on symptoms improvement in the adolescents with one type of anxiety disorders: A double-blind randomized controlled trial
This study was designed to investigate the effect of combining D-cycloserine (DCS) and cognitive-behavioral therapy (CBT) on the adolescents with at least one type of anxiety disorders. The present study was conducted as a double-blind randomized controlled trial on thirty six adolescents with anxiety disorders in an eight-month period (from September, 2011 to May, 2012) who were assessed in two groups. In this study both patients and the information collectors were unaware about the groups' type. The adolescents with the age of 12- to 20-years and anxiety disorders needing therapeutic interventions and receiving anti-anxiety treatment according to the children psychiatrist, with the Lack of any background pertaining to serious psychological or physical problems, mood disorders, psychosis or delusional disorders and drug dependency, without any changes in taking anti-anxiety drugs or any changes in their doses during the last four weeks, the patients with no learning disorders based on the mental check-up, with the absence of background associated with seizure and severe depression with the suicide thoughts and the IQ equal or higher than 80 (it was measured applying Raven Test and by an independent psychiatrist approval) are included in the study. If the patients were absent for more than one session or their parents or themselves did not intend to continue the treatment they were excluded. Patients were selected in a simple non-random manner and in the order of referring to the clinic and were randomly divided into two eighteen-members groups of case and control by the random-maker software "Random Allocation". In addition to four CBT sessions weekly in both groups. Cases received 50-mg DCS capsules and controls received placebo daily for a month, patients received DCS capsules or placebo one hour before CBT sessions . Age, sex, kind of anxiety disorders “SCARED” and “CATS” scores were evaluated and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012071610297N1
Registration date:2013-08-21, 1392/05/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-21, 1392/05/30
Registrant information
Name
Leili Allahbakhshian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7079
Email address
allahbakhshian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, School of Medicine,Vice Chancellor for Research
Expected recruitment start date
2011-09-01, 1390/06/10
Expected recruitment end date
2012-04-30, 1391/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of augment of D-Cycloserine and cognitive-behavioral therapy on symptoms improvement in the adolescents with one type of anxiety disorders: A double-blind randomized controlled trial
Public title
The efficacy of D-Cycloserine and psychotherapy on symptoms improvement in the adults with anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- The adolescents with the age of 12-20 years with anxiety disorders needing therapeutic interventions and receiving anti-anxiety treatment according to the children psychiatrist, 2- Lack of any background pertaining to serious psychological or physical problems, mood disorders, psychosis or delusional disorders and drug dependency,3- Lack of any changes in anti-anxiety drugs or any changes in their doses during 4 weeks before the study,4- Lack of learning disorders based on mental check-up,5- lack of any background associated with seizure and severe depression coupled with the thoughts of suicide, 6- The IQ equal or higher than 80 (it was measured applying Raven Test and by an independent psychiatrist) are of inclusion criteria. Exclusion Criteria: 1-The patients who were absent for more than one session and those whose parents or themselves did not intend to continue the treatment.
Age
From 12 years old to 20 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
36
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
Isfahan University of Medical Sciences, Ethics Committee
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq.
City
Isfahan
Postal code
Approval date
2011-04-20, 1390/01/31
Ethics committee reference number
390609
Health conditions studied
1
Description of health condition studied
Anxiety Disorders
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Improvement of the anxiety disorders symptoms
Timepoint
One month after the beginning of the medication and psychotherapy
Method of measurement
“SCARED” score
Secondary outcomes
1
Description
Children's Automatic Thoughts Scale Score
Timepoint
Three months post treatment
Method of measurement
CATS questionnaire
Intervention groups
1
Description
Case group received a 50-mg D-cycloserine capsule (made in pharmacology school of Isfahan University of Medical Sciences) daily for a month in addition to the psychotherapy.
Category
Treatment - Drugs
2
Description
Control group, received Placebo (made in pharmacology school of Isfahan University of Medical Sciences) daily for a month in addition to the sychotherapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Child and Adolescent Psychiatry
Full name of responsible person
Dr. Ali Soheilimehr
Street address
No.3, Nikoo Building, Shamsabadi Ave., Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, School of Medicine, Vice Chancellor for Research
Full name of responsible person
Dr. Taleb Azarm
Street address
Isfahan University of Medical Sciences, School of Medicine, Vice Chancellor for Research
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, School of Medicine, Vice Chancellor for Research
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, Isfahan University of Medical Sciences
Full name of responsible person
Ali Soheilimehr
Position
Psychiatrist
Other areas of specialty/work
Street address
School of Medicine, Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq.
City
Isfahan
Postal code
Phone
+98 31 1792 3011
Fax
Email
alisoheilimehr@yahoo.com, soroorarman@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Psychiatry, Isfahan University of Medical Sciences,
Full name of responsible person
Dr. Soroor Arman
Position
Psychiatrist
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave, Azadi Sq.
City
Isfahan
Postal code
Phone
+98 31 1222 2222
Fax
Email
soroorarman@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ali Soheilimehr
Position
Psychiatrist
Other areas of specialty/work
Street address
Department of Psychiatry, Medical School, Isfahan University of Medical Sciences, Hezar Jarib Ave. Azadi Sq.
City
Isfahan
Postal code
Phone
Fax
Email
alisoheilimehr@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)