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ARIpiprazole in Anorexia NErvosa (ARIANE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Juan A. Arnaiz, Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona Identifier:
First received: March 8, 2010
Last updated: February 21, 2013
Last verified: February 2013
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:

Further study details as provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Eating Disorder Inventory-2 [ Time Frame: 6 months ]
  • Eating attitudes test (EAT) [ Time Frame: 6 months ]
  • Brown Assessment of Beliefs Scale (BABS) [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • BMI [ Time Frame: 6 months ]
    Body mass index

  • BDI [ Time Frame: 6 months ]
    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


Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01082848

Contact: Jaime Moyá, MD 0034932275400 ext 3482

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

Responsible Party: Juan A. Arnaiz, Dr, Hospital Clinic of Barcelona Identifier: NCT01082848     History of Changes
Other Study ID Numbers: ARIANE
2009-010082-23 ( EudraCT Number )
Study First Received: March 8, 2010
Last Updated: February 21, 2013

Additional relevant MeSH terms:
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on August 18, 2017