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ARIpiprazole in Anorexia NErvosa (ARIANE)

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ClinicalTrials.gov Identifier: NCT01082848
Recruitment Status : Unknown
Verified February 2013 by Juan A. Arnaiz, Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
First Posted : March 9, 2010
Last Update Posted : February 22, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Drug: aripiprazole Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : March 2010
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: aripiprazole Drug: aripiprazole
10 mg QD during 26 weeks
Placebo Comparator: placebo Drug: placebo
QD during 26 weeks


Outcome Measures

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

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

  2. BDI [ Time Frame: 6 months ]
    Beck Depression Inventory


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( EudraCT Number )
First Posted: March 9, 2010    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013

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