ARIpiprazole in Anorexia NErvosa
ARIANE
Efficacy of Aripiprazole in the Treatment of Anorexia Nervosa in Teenagers: a Pilot, Randomised, Double Blind, Placebo-controlled Clinical Trial
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 8, 2010
CompletedFirst Posted
Study publicly available on registry
March 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFebruary 22, 2013
February 1, 2013
3 years
March 8, 2010
February 21, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
Eating Disorder Inventory-2
6 months
Eating attitudes test (EAT)
6 months
Brown Assessment of Beliefs Scale (BABS)
6 months
Secondary Outcomes (2)
BMI
6 months
BDI
6 months
Study Arms (2)
aripiprazole
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- psychotic illness
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Juan A. Arnaizlead
Study Sites (1)
Hospital Clinic
Barcelona, Catalonia, 08036, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
March 8, 2010
First Posted
March 9, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 22, 2013
Record last verified: 2013-02