Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2010-03-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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aripiprazole
aripiprazole
10 mg QD during 26 weeks
placebo
placebo
QD during 26 weeks
Interventions
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aripiprazole
10 mg QD during 26 weeks
placebo
QD during 26 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
18 Years
ALL
No
Sponsors
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Juan A. Arnaiz
OTHER
Responsible Party
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Juan A. Arnaiz
Dr
Locations
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Hospital Clinic
Barcelona, Catalonia, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2009-010082-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ARIANE
Identifier Type: -
Identifier Source: org_study_id
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