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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
  Purpose

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.


Condition Intervention Phase
Anorexia Nervosa
 Drug: aripiprazole
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Aripiprazole in the Treatment of Anorexia Nervosa in Teenagers: a Pilot, Randomised, Double Blind, Placebo-controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aripiprazole Drug: aripiprazole
10 mg QD during 26 weeks
Placebo Comparator: placebo Drug: placebo
QD during 26 weeks

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082848

Contacts
Contact: Jaime Moyá, MD 0034932275400 ext 3482 jmoya1@clinic.ub.es

Locations
Spain
Hospital Clinic Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Jaime Moyá, MD     0034932275400 ext 3482     jmoya1@clinic.ub.es    
Principal Investigator: Jaime Moyá, MD            
Sponsors and Collaborators
Juan A. Arnaiz
  More Information

No publications provided

Responsible Party: Juan A. Arnaiz, Dr, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01082848     History of Changes
Other Study ID Numbers: ARIANE, 2009-010082-23
Study First Received: March 8, 2010
Last Updated: February 21, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2013