Anorexia NervosaPhase 4NCT00592930
Olanzapine in the Treatment of Anorexia Nervosa
A Phase 4 study testing olanzapine in people with Anorexia Nervosa, run by Northwell Health at 1 site in United States.
Trial summary
This study compared 10 weeks of treatment with olanzapine versus placebo in adolescent females with anorexia nervosa-restricting type who were undergoing acute treatment on an inpatient unit or a day hospital program that specializes in the treatment of eating disorders. Read more about this study
- Who is it for?
- Ages 12 to 23 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to Dec 2004
- Phase
- Phase 4
- 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 23 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Females, ages 12-23
Who cannot join
- Binge-purge type
Trial locations and contacts
1 site in 1 country.
United States1 site
Schneider Children's Hospital
New Hyde Park, New York, 11040
About this study
Official title: Pilot Study of the Efficacy of Olanzapine in the Treatment of Anorexias Nervosa
This study compared 10 weeks of treatment with olanzapine versus placebo in adolescent females with anorexia nervosa-restricting type who were undergoing acute treatment on an inpatient unit or a day hospital program that specializes in the treatment of eating disorders.
- Conditions
- Anorexia Nervosa
- Being tested
- olanzapine, placebo
- Keywords
- anorexia nervosa, treatment, adolescents, olanzapine
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
flexibly dosed oral olanzapine 2.5 to 15 mg/day
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | olanzapine Receives: Drug: olanzapine |
| 2 | Placebo comparator | matching placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
Measured: 10 weeks
Secondary outcomes (1)
measures of psychiatric symptoms
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJun 2000
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- Vivian Kafantaris, M.D., Principal investigator, Schneider Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592930
- Sponsor's protocol ID
- 99-04-072
- Other IDs
- Lilly F1D-US-X166
- Status last verified
- Jan 2008
- First submitted
- 2 Jan 2008
- Last updated
- 14 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Kafantaris V, Leigh E, Hertz S, Berest A, Schebendach J, Sterling WM, Saito E, Sunday S, Higdon C, Golden NH, Malhotra AK. A placebo-controlled pilot study of adjunctive olanzapine for adolescents with anorexia nervosa. J Child Adolesc Psychopharmacol. 2011 Jun;21(3):207-12. doi: 10.1089/cap.2010.0139.
PubMed 21663423
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Efficacy of Olanzapine in the Treatment of Anorexias Nervosa
- ClinicalTrials.gov ID
- NCT00592930
- Acronym / sponsor ID
- 99-04-072
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, treatment, adolescents, olanzapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jun 2000
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004
- First posted
- 14 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.
This study compared 10 weeks of treatment with olanzapine versus placebo in adolescent females with anorexia nervosa-restricting type who were undergoing acute treatment on an inpatient unit or a day hospital program that specializes in the treatment of eating disorders.
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 |
|---|---|---|
| 1 | Experimental | Drug: olanzapineolanzapine |
| 2 | Placebo comparator | Drug: placebomatching placebo |
Who may qualify
- Ages
- 12 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Females, ages 12-23
Key exclusion criteria (1 listed)
- Binge-purge type
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 |
|---|---|---|
| olanzapineflexibly dosed oral olanzapine 2.5 to 15 mg/day | Drug | 1 |
| placebo | Drug | 2 |
Primary outcome
weight gain
Time frame: 10 weeks
1 secondary outcome
measures of psychiatric symptoms
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2008.
- Derived from this study: PubMed 21663423Kafantaris V, Leigh E, Hertz S, Berest A, Schebendach J, Sterling WM, Saito E, Sunday S, Higdon C, Golden NH, Malhotra AK. A placebo-controlled pilot study of adjunctive olanzapine for adolescents with anorexia nervosa. J Child Adolesc Psychopharmacol. 2011 Jun;21(3):207-12. doi: 10.1089/cap.2010.0139.
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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.
Vivian Kafantaris, M.D. principal investigator
Schneider Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing olanzapine in people with Anorexia Nervosa, run by Northwell Health 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jan 2008. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
weight gain (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00592930, which also lists 1 linked publication.
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 14 Jan 2008.