ARIpiprazole in Anorexia NErvosa (ARIANE)

Juan A. Arnaiz

Status and phase: Unknown; Phase 3

Conditions: Anorexia Nervosa

Treatments: Drug: placebo; Drug: aripiprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01082848

2009-010082-23 (EudraCT Number)

ARIANE

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

aripiprazole

Experimental group

Treatment:

Drug: aripiprazole

placebo

Placebo Comparator group

Treatment:

Drug: placebo