The objective of this study is to assess the efficacy of Ginkgo biloba in the treatment of autism. Fourty children between the ages 3 and 12 years with a DSM IV clinical diagnosis of autism and who will be outpatients will be recruited. The children should present with a chief complaint of severely disruptive symptoms related to autistic disorder. Patients will be randomly allocated into Ginkgo biloba (80- 120 mg/day) + Risperidone (3.5mg/day) or Placebo + Risperidone (3.5mg/day) for a 10-week, double-blind, placebo-controlled study. Patients will be assessed at baseline and after 2, 4, 6, 8 and 10 weeks of starting medication. The primary outcome measure is the Aberrant Behavior Checklist-Community (ABC-C) Rating Scale (total score).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012031556N19
Registration date:2010-12-04, 1389/09/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-04, 1389/09/13
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Tehran University of Medical Sciences
2- Kurdistan University of Medical Sciences-Sanandaj-Iran
Expected recruitment start date
2010-04-06, 1389/01/17
Expected recruitment end date
2011-10-06, 1390/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double - blind placebo controlled trial of Ginkgo Biloba added to risperidone in patint with autistic disorder
Public title
Ginkgo biloba in the treatment of autistic disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: DSM IV clinical diagnosis of autism, children and adolescents between the ages of 3 and 12 years (inclusive), Exclusion Criteria: Presence of any active medical problem, any diagnosis in Axis I and II except for mental retatdation, history of allergy to Ginkgo Biloba, receiving any psychotropic medications during past two weeks prior to the trial
Age
From 3 years old to 12 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
ٍEthics Committee of Tehran University of Medical Sciences