ARIpiprazole in Anorexia NErvosa

Anorexia Nervosa Clinical Trial

— ARIANE  

Official title:

Efficacy of Aripiprazole in the Treatment of Anorexia Nervosa in Teenagers: a Pilot, Randomised, Double Blind, Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01082848
• Other study ID #: ARIANE
• Secondary ID: 2009-010082-23
• Status: Recruiting
• Phase: Phase 3
• First received: March 8, 2010
• Last updated: February 21, 2013
• Start date: March 2010
• Est. completion date: March 2013

Study information

• Verified date: February 2013
• Source: Hospital Clinic of Barcelona
• Contact: Jaime Moyá, MD
• Phone: 0034932275400
• Email: jmoya1[@]clinic.ub.es
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Drug:
• aripiprazole
10 mg QD during 26 weeks
• placebo
QD during 26 weeks

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eating Disorder Inventory-2		6 months	No
Primary	Eating attitudes test (EAT)		6 months	No
Primary	Brown Assessment of Beliefs Scale (BABS)		6 months	No
Secondary	BMI	Body mass index	6 months	No
Secondary	BDI	Beck Depression Inventory	6 months	No