ARIpiprazole in Anorexia NErvosa

Juan A. Arnaiz60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Anorexia Nervosa

Interventions

aripiprazoleDRUG

10 mg QD during 26 weeks

placeboDRUG

QD during 26 weeks

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Clinic

Barcelona, Catalonia, Spain

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

BMI

Body mass index

Time frame: 6 months

BDI

Beck Depression Inventory

Time frame: 6 months

Central Contacts

Jaime Moyá, MD

CONTACT

0034932275400 jmoya1@clinic.ub.es

Data from ClinicalTrials.gov

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