ARIpiprazole in Anorexia NErvosa

NCT ID: NCT01082848

Last Updated: 2013-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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aripiprazole

Group Type EXPERIMENTAL

aripiprazole

Intervention Type DRUG

10 mg QD during 26 weeks

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

QD during 26 weeks

Interventions

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aripiprazole

10 mg QD during 26 weeks

Intervention Type DRUG

placebo

QD during 26 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juan A. Arnaiz

OTHER

Sponsor Role lead

Responsible Party

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Juan A. Arnaiz

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Clinic

Barcelona, Catalonia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jaime Moyá, MD

Role: CONTACT

0034932275400 ext. 3482

Facility Contacts

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Jaime Moyá, MD

Role: primary

0034932275400 ext. 3482

Other Identifiers

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2009-010082-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ARIANE

Identifier Type: -

Identifier Source: org_study_id

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