Anorexia NervosaPhase 3ARIANENCT01082848
ARIpiprazole in Anorexia NErvosa
A Phase 3 study testing aripiprazole in people with Anorexia Nervosa, run by Juan A. Arnaiz at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- aripiprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2010to Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- psychotic illness
- antipsychotic therapy at inclusion
- pregnancy and breastfeeding
- antipsychotic drug allergy
- prior head trauma, malignant neuroleptic syndrome or epilepsy
- relevant comorbidities requiring therapy
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, Catalonia, 08036
Jaime Moyá, MD, 0034932275400 ext. 3482, jmoya1@clinic.ub.es
Jaime Moyá, MD
About this study
Official title: Efficacy of Aripiprazole in the Treatment of Anorexia Nervosa in Teenagers: a Pilot, Randomised, Double Blind, Placebo-controlled Clinical Trial
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.
- Conditions
- Anorexia Nervosa
- Being tested
- aripiprazole, placebo
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazoleDrug
10 mg QD during 26 weeks
placeboDrug
QD during 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| aripiprazole | Experimental | Not described Receives: Drug: aripiprazole |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Inventory-2
Measured: 6 months
Eating attitudes test (EAT)
Measured: 6 months
Brown Assessment of Beliefs Scale (BABS)
Measured: 6 months
Secondary outcomes (2)
BMI
Body mass index
Measured: 6 months
BDI
Beck Depression Inventory
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan A. Arnaiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan A. Arnaiz, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082848
- Sponsor's protocol ID
- ARIANE
- Other IDs
- 2009-010082-23, 2009
- Acronym
- ARIANE
- Status last verified
- Feb 2013
- First submitted
- 8 Mar 2010
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Aripiprazole in the Treatment of Anorexia Nervosa in Teenagers: a Pilot, Randomised, Double Blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01082848
- Acronym / sponsor ID
- ARIANE / ARIANE
- Conditions
- Anorexia Nervosa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Juan A. ArnaizUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aripiprazole | Experimental | Drug: aripiprazole |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- psychotic illness
- antipsychotic therapy at inclusion
- pregnancy and breastfeeding
- antipsychotic drug allergy
- prior head trauma, malignant neuroleptic syndrome or epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aripiprazole10 mg QD during 26 weeks | Drug | aripiprazole |
| placeboQD during 26 weeks | Drug | placebo |
Primary outcome
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
2 secondary outcomes
BMI
Time frame: 6 months
BDI
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aripiprazole in people with Anorexia Nervosa, run by Juan A. Arnaiz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaime Moyá, MD (0034932275400 ext. 3482, jmoya1@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Inventory-2 (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2013.