SchizophreniaPhase 4NCT00176436
Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients
A Phase 4 study testing Diet support group and Group counseling and exercise in people with Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The study investigates the use of Atomoxetine in combination with exercise and a diet support group (Weight Watchers)to treat weight gain associated with Olanzapine or clozapine. All patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective Disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Diet support group and Group counseling and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Mar 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Schizophrenia or schizoaffective Disorder
- Taking olanzapine or clozapine for at least 6 months
- Weight gain of 7% over baseline or BMI greater than or equal to 27
Who cannot join
- Current treatment with methylphenidate, clonidine, tricyclic antidepressants, bupropion and venlafaxine
- Treatment with other medications known to cause weight gain unless weight stable on medication for 6 months
- Current treatment with other medications for weight loss unless weight stable for 6 months
- Mental Retardation
- Alcohol or Substance Dependence within the last 6 months
- Pregnancy
- Alcohol or Substance Abuse within the lat month
- Uncontrolled hypertension defined as a blood pressure exceeding 140/90 on three consecutive readings despite adequate treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
About this study
Official title: Double-Blind Study of Atomoxetine for Weight Management in Patients Taking Olanzapine or Clozapine
The study investigates the use of Atomoxetine in combination with exercise and a diet support group (Weight Watchers)to treat weight gain associated with Olanzapine or clozapine. All patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective Disorder.
Read the detailed description
The study is a 6 month double-blind trial of atomoxetine in combination with a Weight Watchers group to help patients lose the weight they have gained taking olanzapine or clozapine. All participants should have been on Olanzapine or clozapine for at least 6 months and gained 7% of baseline weight or have a BMI of 27 or greater. In addition to the group support, participants are provided supervised exercise sessions and medical supervision. Previous studies of the group process alone were successful in helping patients lose weight. It is hoped that the addition of atomoxetine, which is known to cause appetite suppression, will be more effective in helping subjects lose weight. All subjects will receive either atomoxetine or placebo during the 6 month study.
- Conditions
- Schizophrenia
- Being tested
- Diet support group, Group counseling and exercise
- Keywords
- Weight loss, Support group, Exercise, Atomoxetine
- Medical subject headings
- Schizophrenia, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet support groupBehavioural
Diet support group weekly and exercise sessions 3 times/week, placebo medication
Group counseling and exerciseBehavioural
Support group weekly and exercise sessions 3 times/week for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| active | Active comparator | Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24. Diet support group, group counseling and exercise. Receives: Behavioral: Group counseling and exercise |
| Placebo | Placebo comparator | Placebo medication, diet support group, group counseling and exercise Receives: Behavioral: Diet support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Weight
Weight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups.
Measured: Weekly for 24 weeks
Secondary outcomes (3)
Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function.
Measured: 24 weeks
Vital Signs
Measured: Weekly for 24 weeks
Chemistry Panel
Measured: baseline, 10 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Robert Buchanan, University of Maryland, Baltimore
- Investigators
- M Patricia Ball, R.N.,C.,M.S., Principal investigator, University of Maryland Baltimore Maryland Psychiatric Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176436
- Sponsor's protocol ID
- H-21874
- Other IDs
- F1D-US-X254
- Status last verified
- Mar 2022
- First submitted
- 12 Sep 2005
- Last updated
- 14 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ball MP, Warren KR, Feldman S, McMahon RP, Kelly DL, Buchanan RW. Placebo-controlled trial of atomoxetine for weight reduction in people with schizophrenia treated with clozapine or olanzapine. Clin Schizophr Relat Psychoses. 2011 Apr;5(1):17-25.
PubMed 21459735
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Study of Atomoxetine for Weight Management in Patients Taking Olanzapine or Clozapine
- ClinicalTrials.gov ID
- NCT00176436
- Acronym / sponsor ID
- H-21874
- Conditions
- Schizophrenia
- Keywords
- Weight loss, Support group, Exercise, Atomoxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Feb 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 17 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates the use of Atomoxetine in combination with exercise and a diet support group (Weight Watchers)to treat weight gain associated with Olanzapine or clozapine. All patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective Disorder.
Detailed description
The study is a 6 month double-blind trial of atomoxetine in combination with a Weight Watchers group to help patients lose the weight they have gained taking olanzapine or clozapine. All participants should have been on Olanzapine or clozapine for at least 6 months and gained 7% of baseline weight or have a BMI of 27 or greater. In addition to the group support, participants are provided supervised exercise sessions and medical supervision. Previous studies of the group process alone were successful in helping patients lose weight. It is hoped that the addition of atomoxetine, which is known to cause appetite suppression, will be more effective in helping subjects lose weight. All subjects will receive either atomoxetine or placebo during the 6 month study.
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 |
|---|---|---|
| active | Active comparator | Behavioral: Group counseling and exerciseAtomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24. Diet support group, group counseling and exercise. |
| Placebo | Placebo comparator | Behavioral: Diet support groupPlacebo medication, diet support group, group counseling and exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Schizophrenia or schizoaffective Disorder
- Taking olanzapine or clozapine for at least 6 months
- Weight gain of 7% over baseline or BMI greater than or equal to 27
Key exclusion criteria (8 listed)
- Current treatment with methylphenidate, clonidine, tricyclic antidepressants, bupropion and venlafaxine
- Treatment with other medications known to cause weight gain unless weight stable on medication for 6 months
- Current treatment with other medications for weight loss unless weight stable for 6 months
- Mental Retardation
- Alcohol or Substance Dependence within the last 6 months
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 |
|---|---|---|
| Diet support groupDiet support group weekly and exercise sessions 3 times/week, placebo medication | Behavioural | Placebo |
| Group counseling and exerciseSupport group weekly and exercise sessions 3 times/week for 24 weeks | Behavioural | active |
Primary outcome
Change From Baseline in Weight
Time frame: Weekly for 24 weeks
Weight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups.
3 secondary outcomes
Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function.
Time frame: 24 weeks
Vital Signs
Time frame: Weekly for 24 weeks
Chemistry Panel
Time frame: baseline, 10 weeks and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21459735Ball MP, Warren KR, Feldman S, McMahon RP, Kelly DL, Buchanan RW. Placebo-controlled trial of atomoxetine for weight reduction in people with schizophrenia treated with clozapine or olanzapine. Clin Schizophr Relat Psychoses. 2011 Apr;5(1):17-25.
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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.
M Patricia Ball, R.N.,C.,M.S. principal investigator
University of Maryland Baltimore Maryland Psychiatric Research Center
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 Diet support group and Group counseling and exercise in people with Schizophrenia, run by University of Maryland, Baltimore 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 3 inclusion and 8 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 Mar 2022. 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?
Yes. Results are posted in the registry (first posted 17 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Weight (time frame: Weekly for 24 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 NCT00176436, 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 Mar 2022.