ARIpiprazole in Anorexia NErvosa (ARIANE)

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.

Study Overview

• Status: Unknown
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Drug: aripiprazole; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jaime Moyá, MD

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Recruiting
      • Hospital Clínic
      • Contact: Jaime Moyá, MD; Phone Number: 3482 0034932275400; Email: jmoya1@clinic.ub.es
      • Principal Investigator: Jaime Moyá, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; QD during 26 weeks
Experimental: aripiprazole	Drug: aripiprazole; 10 mg QD during 26 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eating Disorder Inventory-2	6 months
Eating attitudes test (EAT)	6 months
Brown Assessment of Beliefs Scale (BABS)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Body mass index	6 months
BDI	Beck Depression Inventory	6 months

Collaborators and Investigators

• Sponsor: Juan A. Arnaiz

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: March 8, 2010
• First Submitted That Met QC Criteria: March 8, 2010
• First Posted (Estimate): March 9, 2010

Study Record Updates

• Last Update Posted (Estimate): February 22, 2013
• Last Update Submitted That Met QC Criteria: February 21, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: ARIANE; 2009-010082-23 (EudraCT Number)