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ARIpiprazole in Anorexia NErvosa (ARIANE)

This study is currently recruiting participants.
Verified February 2013 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01082848
First received: March 8, 2010
Last updated: February 21, 2013
Last verified: February 2013
History of Changes

March 8, 2010
February 21, 2013
March 2010
March 2013   (final data collection date for primary outcome measure)
  • Eating Disorder Inventory-2 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Eating attitudes test (EAT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Brown Assessment of Beliefs Scale (BABS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01082848 on ClinicalTrials.gov Archive Site
  • BMI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Body mass index
  • BDI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Beck Depression Inventory
Same as current
Not Provided
Not Provided
 
ARIpiprazole in Anorexia NErvosa
Efficacy of Aripiprazole in the Treatment of Anorexia Nervosa in Teenagers: a Pilot, Randomised, Double Blind, Placebo-controlled Clinical Trial

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anorexia Nervosa
  • Drug: aripiprazole
    10 mg QD during 26 weeks
  • Drug: placebo
    QD during 26 weeks
  • Experimental: aripiprazole
    Intervention: Drug: aripiprazole
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
12 Years to 18 Years
No
Contact: Jaime Moyá, MD 0034932275400 ext 3482 jmoya1@clinic.ub.es
Spain
 
NCT01082848
ARIANE, 2009-010082-23
No
Juan A. Arnaiz, Hospital Clinic of Barcelona
Juan A. Arnaiz
Not Provided
Not Provided
Hospital Clinic of Barcelona
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP