Anorexia NervosaPhase 2NCT00584688
A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study
A Phase 2 study testing quetiapine in people with Anorexia Nervosa, run by University of South Florida at 1 site in United States.
Trial summary
Research studies raise the possibility that medications such as quetiapine may improve mood or reduce obsessions in people with anorexia nervosa and may even help to normalize appetite. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- quetiapine
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Aug 2009
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be aged 18-65
- Must be at least 15% below ideal body weight
Who cannot join
- Allergy to quetiapine
- Diagnosis of schizophrenia
Trial locations and contacts
1 site in 1 country.
About this study
Research studies raise the possibility that medications such as quetiapine may improve mood or reduce obsessions in people with anorexia nervosa and may even help to normalize appetite. The medication quetiapine also known as seroquel works by activating certain systems in the brain, such as ones known as dopamine and serotonin chemical systems in the brain.
- Conditions
- Anorexia Nervosa
- Being tested
- quetiapine
- Keywords
- anorexia, nervosa, eating, disorder, study, research, clinical, trial, psychiatry, psychiatric
- Medical subject headings
- Anorexia Nervosa, Anorexia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quetiapineDrug
quetiapine dosage will be titrated to subject tolerance beginning at 50 mg every 24 hours upwards to 400 mg every 24 hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine efficacy of seroquel in anorexia nervosa
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startFeb 2007
- Primary completionJun 2009
- Study completionAug 2009
Why it stopped: Lack of Enrollment
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.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584688
- Sponsor's protocol ID
- 0825
- Status last verified
- Mar 2009
- First submitted
- 21 Dec 2007
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study
- ClinicalTrials.gov ID
- NCT00584688
- Acronym / sponsor ID
- 0825
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia, nervosa, eating, disorder, study, research, clinical, trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Enrollment
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- Feb 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Jan 2008 (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.
Research studies raise the possibility that medications such as quetiapine may improve mood or reduce obsessions in people with anorexia nervosa and may even help to normalize appetite. The medication quetiapine also known as seroquel works by activating certain systems in the brain, such as ones known as dopamine and serotonin chemical systems in the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be aged 18-65
- Must be at least 15% below ideal body weight
Key exclusion criteria (2 listed)
- Allergy to quetiapine
- Diagnosis of schizophrenia
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 |
|---|---|---|
| quetiapinequetiapine dosage will be titrated to subject tolerance beginning at 50 mg every 24 hours upwards to 400 mg every 24 hours. | Drug | – |
Primary outcome
To determine efficacy of seroquel in anorexia nervosa
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Lack of Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing quetiapine in people with Anorexia Nervosa, run by University of South Florida at 1 site in United States.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 18 Jun 2012. 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 United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of Enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine efficacy of seroquel in anorexia nervosa (time frame: 8 weeks). 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 18 Jun 2012.