ARIpiprazole in Anorexia NErvosa (ARIANE)
Primary Purpose
Anorexia Nervosa
Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
aripiprazole
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa
Eligibility Criteria
Inclusion Criteria:
- age between 12 and 18
- diagnostic criteria for anorexia Nervosa (DSM-IV-TR (includes BMI below 17.5kg/m2 and above 14 kg/m2) confirmed by a Psychiatrist and validated by K-SADS-PL interview
- severity criteria requiring Hospital admission
- Consent given by parents and patients
Exclusion Criteria:
- psychotic illness
- antipsychotic therapy at inclusion
- pregnancy and breastfeeding
- antipsychotic drug allergy
- prior head trauma, malignant neuroleptic syndrome or epilepsy
- relevant comorbidities requiring therapy
- detection of abuse drugs in urine test
- treatment with neuroleptic, antidepressant or mood stabilizers during 2 weeks prior to randomization (4 weeks in case of fluoxetine)
- suicidal or homicidal thoughts
- IQ below 70
Sites / Locations
- Hospital ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
aripiprazole
placebo
Arm Description
Outcomes
Primary Outcome Measures
Eating Disorder Inventory-2
Eating attitudes test (EAT)
Brown Assessment of Beliefs Scale (BABS)
Secondary Outcome Measures
BMI
Body mass index
BDI
Beck Depression Inventory
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01082848
Brief Title
ARIpiprazole in Anorexia NErvosa
Acronym
ARIANE
Official Title
Efficacy of Aripiprazole in the Treatment of Anorexia Nervosa in Teenagers: a Pilot, Randomised, Double Blind, Placebo-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan A. Arnaiz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evidence is lacking on the effects of different psychotropic drugs in the treatment of anorexia nervosa (AR). However, HVA levels seem to be elevated in this disease, therefore suggesting a role for drugs with a partial agonist profile on dopaminergic receptors. This is a pilot study assessing the effects of aripiprazole in teenagers with AR, compared with a placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aripiprazole
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
aripiprazole
Intervention Description
10 mg QD during 26 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
QD during 26 weeks
Primary Outcome Measure Information:
Title
Eating Disorder Inventory-2
Time Frame
6 months
Title
Eating attitudes test (EAT)
Time Frame
6 months
Title
Brown Assessment of Beliefs Scale (BABS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
BMI
Description
Body mass index
Time Frame
6 months
Title
BDI
Description
Beck Depression Inventory
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 12 and 18
diagnostic criteria for anorexia Nervosa (DSM-IV-TR (includes BMI below 17.5kg/m2 and above 14 kg/m2) confirmed by a Psychiatrist and validated by K-SADS-PL interview
severity criteria requiring Hospital admission
Consent given by parents and patients
Exclusion Criteria:
psychotic illness
antipsychotic therapy at inclusion
pregnancy and breastfeeding
antipsychotic drug allergy
prior head trauma, malignant neuroleptic syndrome or epilepsy
relevant comorbidities requiring therapy
detection of abuse drugs in urine test
treatment with neuroleptic, antidepressant or mood stabilizers during 2 weeks prior to randomization (4 weeks in case of fluoxetine)
suicidal or homicidal thoughts
IQ below 70
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Moyá, MD
Phone
0034932275400
Ext
3482
Email
jmoya1@clinic.ub.es
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Moyá, MD
Phone
0034932275400
Ext
3482
Email
jmoya1@clinic.ub.es
First Name & Middle Initial & Last Name & Degree
Jaime Moyá, MD
12. IPD Sharing Statement
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ARIpiprazole in Anorexia NErvosa
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