Protocol summary
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Study aim
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Evaluation the efficacy of a syrup of Echium Amoenum-Melissa Officinalis in treatment of adolescents with Obsessive-Compulsive Disorder
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Design
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Randomized clinical trial, including intervention and control groups with parallel groups, double-blind
The random allocation sequence using the random number table is www.randomization.com.
The method of allocation concealment: indoor envelopes. The sample size is 20 people in each group.
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Settings and conduct
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Recruitment center: Child Psychaitry clinic at Ibn-e-Sina hospital
Patients are evaluated by pediatric psychiatrist with Yale Brown Obsessive-Compulsive questionnaire in children and divided into intervention and control groups by simple randomization method. Patients and outcome assessors are unaware of the individuals assigned to the groups.The Yale Brown Obsessive-Compulsive questionnaire for Children is administered in week 4 and 8 of the study and questionnaires of quality of life, Anxiety, and Depression are completed at the beginning and end of the study for patients.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Obsessive-Compulsive Disorder with a diagnosis of pediatric psychiatry according to DSM-5 criteria; Ages 13 to 17 years
Exclusion criteria:
Psychosis; Bipolar disorder; Catatonic symptoms; Drug abuse; Severe or debilitating illnesses; Phenobarbital consumption; Oxazepam consumption; Sedative drugs consumption
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Intervention groups
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Intervention group will receive a herbal syrup, 0.3 milliliter per kilogram of body weight and 50 mg Fluvoxamine tablets daily and the control group will receive placebo syrup and 50 mg Fluvoxamine tablets daily for 8 weeks.
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Main outcome variables
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Obsessive score on children's Yale-Brown Obsessive Compulsive questionnaire
General information
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Reason for update
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Need to limit the target group to adolescents to standardize the dose of the drug; Inclusion of all adolescents with obsessive-compulsive disorder (of varying severity) in the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191127045521N1
Registration date:
2019-12-05, 1398/09/14
Registration timing:
prospective
Last update:
2021-05-12, 1400/02/22
Update count:
1
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Registration date
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2019-12-05, 1398/09/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-12-22, 1398/10/01
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Expected recruitment end date
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2020-12-21, 1399/10/01
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Actual recruitment start date
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2020-01-21, 1398/11/01
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Actual recruitment end date
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2021-01-27, 1399/11/08
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Trial completion date
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2021-03-25, 1400/01/05
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Scientific title
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Evaluation the efficacy of a syrup of Echium amoenum-Melissa officinalis in treatment of adolescents with Obsessive-Compulsive Disorder
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Public title
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Evaluation the efficacy of a syrup of Echium amoenum-Melissa officinalis in treatment of adolescents with Obsessive-Compulsive Disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Obsessive-Compulsive Disorder with a diagnosis of pediatric psychiatry according to DSM-5 criteria
Ages 13 to 17 years
Exclusion criteria:
Psychosis
Bipolar disorder
Catatonic symptoms
Drug abuse
Severe or debilitating illnesses
Phenobarbital consumption
Oxazepam consumption
Sedative drugs consumption
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Age
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From 13 years old to 17 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
40
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are divided into Intervention and control groups using simple randomization (www.randomization.com). How to hide the allocation is with closed envelopes.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patients in this study are unaware that they are assigned to a control or intervention group. Intervention group will receive Echium amoenum-Melissa officinalis syrup and fluoxamine tablets. Control group will receive placebo and fluoxamine tablets.The outcome assessor is also unaware of which group the patient belongs to.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-09-21, 1398/06/30
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Ethics committee reference number
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IR.MUMS.REC.1398.221
Health conditions studied
1
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Description of health condition studied
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Obsessive-Compulsive Disorder
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ICD-10 code
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F42.2
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ICD-10 code description
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Mixed obsessional thoughts and acts
Primary outcomes
1
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Description
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Obsessive score on children's Yale-Brown Obsessive Compulsive questionnaire
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Timepoint
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pretest, 4 weeks after beginning, post-test (at the end of 8 weeks)
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Method of measurement
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children's Yale-Brown Obsessive Compulsive questionnaire
Secondary outcomes
1
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Description
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Quality of life score
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Timepoint
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pretest, post-test (at the end of 8 weeks)
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Method of measurement
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The World Health Organization Quality of Life Questionnaire
2
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Description
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Anxiety score
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Timepoint
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pretest, 4 weeks after beginning, post-test (at the end of 8 weeks)
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Method of measurement
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Spence Children's Anxiety Questionnaire
3
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Description
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Depression score
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Timepoint
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pretest, 4 weeks after beginning, post-test (at the end of 8 weeks)
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Method of measurement
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Maria Kovas Depression Questionnaire
Intervention groups
1
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Description
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Intervention group will receive a Echium amoenum-Melissa officinalis syrup, 0.3 milliliter per kilogram of body weight and 50 mg Fluvoxamine tablets daily for 8 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group will receive placebo syrup and 50 mg Fluvoxamine tablets daily for 8 weeks.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available