ARIpiprazole in Anorexia NErvosa

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01082848

Acronym

ARIANE

Enrollment

Registered

2010-03-09

Start date

2010-03-31

Completion date

2013-03-31

Last updated

2013-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa

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.

Interventions

DRUGaripiprazole

10 mg QD during 26 weeks

DRUGplacebo

QD during 26 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Contacts

Primary ContactJaime Moyá, MD

jmoya1@clinic.ub.es0034932275400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026