Anxiety in Those Patients With Anorexia NervosaPhase 4NCT01372670
Does Hydroxyzine Decrease Anxiety in Underweight Patients Diagnosed With an Eating Disorder
A Phase 4 study testing Hydroxyzine and hydroxyzine HCL in people with Anxiety in Those Patients With Anorexia Nervosa and Eating Disorder Not Otherwise Specified, BMI (<=18), run by HealthPartners Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of hydroxyzine in the treatment of meal-related anxiety in adolescents and young adults 8 to 25 years of age diagnosed with an eating disorder who are underweight. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Anxiety in Those Patients With Anorexia Nervosa, Eating Disorder Not Otherwise Specified, BMI (<=18)
- What is being tested?
- Hydroxyzine and hydroxyzine HCL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Apr 2013
- 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 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Admitted to the Intensive Structured Living Unit (ISL) at Melrose Institute for treatment of an eating disorder that meets DSM-IV criteria for Anorexia Nervosa (excluding the amenorrhea criterion), or Eating Disorder Not Otherwise Specified, specifically with BMI (≤ 18)
- Age 8-25 years old at admission to ISL.
- Weight ≥ 15 kg at admission to ISL.
- Stable psychotropic and/or sedative medications for at least (≥) 6 weeks
Who cannot join
- Age < 8 years
- Age ≥ 25 years
- Weight < 15 kg at admission to ISL
- Prolonged QT interval on ECG at admission to ISL
- Current substance or alcohol abuse or dependence
- Malabsorption syndrome or inability to take oral medications
Show all 11Show fewer
- History of hydroxyzine intolerance or hypersensitivity
- History of Type 1 Diabetes Mellitus
- History of angle closure glaucoma
- Currently on another clinical trial
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydroxyzine Effects on Meal-Related Anxiety in Underweight Adolescents and Young Adults Diagnosed With an Eating Disorder - A Pilot Study
The purpose of this study is to determine the effectiveness of hydroxyzine in the treatment of meal-related anxiety in adolescents and young adults 8 to 25 years of age diagnosed with an eating disorder who are underweight. The investigators want to find out if hydroxyzine given before meals will improve meal-related anxiety compared to no hydroxyzine.
Read the detailed description
This study is a practiced-based pilot study in follow-up to clinical observations made by our treatment team that hydroxyzine attenuates meal-related anxiety and improves treatment adherence in patients with a diagnosis of Anorexia Nervosa (AN) (excluding the amenorrhea criterion) or Eating Disorder Not Otherwise Specified (EDNOS) specifically with low BMI (≤ 18). To our knowledge, hydroxyzine has never been formally investigated in treating meal-related anxiety and improving outcomes in patients with AN or EDNOS specifically with low BMI (≤ 18).
- Conditions
- Anxiety in Those Patients With Anorexia Nervosa, Eating Disorder Not Otherwise Specified, BMI (<=18)
- Being tested
- Hydroxyzine, hydroxyzine HCL, Placebo
- Keywords
- Treating meal related anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroxyzineDrug
Study medications (hydroxyzine/placebo) will be dosed based on participant's weight. Dosing will be according to the following body weight ranges:
15-29 Kg 10 mg TID 30-44 Kg 20 mg TID
≥ 45 Kg 30 mg TID
hydroxyzine HCLDrug
hydroxyzine HCL dosed on weight given 3x per day
PlaceboOther
Placebo given 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| Hydroxyzine | Experimental | Hydroxyzine given TID Receives: Drug: Hydroxyzine; Drug: hydroxyzine HCL |
| Sugar Pill | Placebo comparator | Placebo given 3 times per day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported anxiety
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Due to unforseen recruiting difficulties, the study was closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety in Those Patients With 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Park Nicollet Eating Disorder Institute
- Responsible party
- Sponsor
- Investigators
- Marcus Westerman, MD, PhD, Principal investigator, Park Nicollet Melrose Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372670
- Sponsor's protocol ID
- 04091-11
- Status last verified
- Feb 2016
- First submitted
- 10 Jun 2011
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxyzine Effects on Meal-Related Anxiety in Underweight Adolescents and Young Adults Diagnosed With an Eating Disorder - A Pilot Study
- ClinicalTrials.gov ID
- NCT01372670
- Acronym / sponsor ID
- 04091-11
- Conditions
- Anxiety in Those Patients With Anorexia Nervosa, Eating Disorder Not Otherwise Specified, BMI (<=18)
- Keywords
- Treating meal related anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to unforseen recruiting difficulties, the study was closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Park Nicollet Eating Disorder Institute
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 14 Jun 2011 (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.
The purpose of this study is to determine the effectiveness of hydroxyzine in the treatment of meal-related anxiety in adolescents and young adults 8 to 25 years of age diagnosed with an eating disorder who are underweight. The investigators want to find out if hydroxyzine given before meals will improve meal-related anxiety compared to no hydroxyzine.
Detailed description
This study is a practiced-based pilot study in follow-up to clinical observations made by our treatment team that hydroxyzine attenuates meal-related anxiety and improves treatment adherence in patients with a diagnosis of Anorexia Nervosa (AN) (excluding the amenorrhea criterion) or Eating Disorder Not Otherwise Specified (EDNOS) specifically with low BMI (≤ 18). To our knowledge, hydroxyzine has never been formally investigated in treating meal-related anxiety and improving outcomes in patients with AN or EDNOS specifically with low BMI (≤ 18).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxyzine | Experimental | Drug: Hydroxyzine, Drug: hydroxyzine HCLHydroxyzine given TID |
| Sugar Pill | Placebo comparator | Other: PlaceboPlacebo given 3 times per day |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Admitted to the Intensive Structured Living Unit (ISL) at Melrose Institute for treatment of an eating disorder that meets DSM-IV criteria for Anorexia Nervosa (excluding the amenorrhea criterion), or Eating Disorder Not Otherwise Specified, specifically with BMI (≤ 18)
- Age 8-25 years old at admission to ISL.
- Weight ≥ 15 kg at admission to ISL.
- Stable psychotropic and/or sedative medications for at least (≥) 6 weeks
Key exclusion criteria (11 listed)
- Age < 8 years
- Age ≥ 25 years
- Weight < 15 kg at admission to ISL
- Prolonged QT interval on ECG at admission to ISL
- Current substance or alcohol abuse or dependence
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 |
|---|---|---|
| HydroxyzineStudy medications (hydroxyzine/placebo) will be dosed based on participant's weight. Dosing will be according to the following body weight ranges: 15-29 Kg 10 mg TID 30-44 Kg 20 mg TID ≥ 45 Kg 30 mg TID | Drug | Hydroxyzine |
| hydroxyzine HCLhydroxyzine HCL dosed on weight given 3x per day | Drug | Hydroxyzine |
| PlaceboPlacebo given 3 times per day | Other | Sugar Pill |
Primary outcome
Self-reported anxiety
Time frame: 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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.
Marcus Westerman, MD, PhD principal investigator
Park Nicollet Melrose Institute
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 Hydroxyzine and hydroxyzine HCL in people with Anxiety in Those Patients With Anorexia Nervosa and Eating Disorder Not Otherwise Specified, BMI (<=18), run by HealthPartners Institute 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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 15 Nov 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
Self-reported anxiety (time frame: 3 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 15 Nov 2016.