Psychotic DisorderPhase 2NCT00350311
Multicomponent Risk Factor Intervention for People With a Severe Mental Illness: a Feasibility Study
A Phase 2 study testing nicotine transdermal patch/lozenge in people with Psychotic Disorder and Obesity, run by The University of New South Wales at 4 sites in Australia.
Trial summary
This study is a feasibility study of a multi-component intervention to enhance healthy living among young people with psychotic disorders, specifically targeting smoking and weight. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Psychotic Disorder, Obesity, Behavior, Addictive
- What is being tested?
- nicotine transdermal patch/lozenge
- How many people
- 43 participants
- Where
- 4 sitesAustralia
- Study dates
- Feb 2007to Apr 2008
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 yrs
- DSM-IV diagnosis of non-organic psychotic illness
- Obesity (BMI > 30 or 27 if co-morbidities such as diabetes, hypertension or dyslipidaemia are present
- Current smoker ( > 15 cigarettes per day) if also smoking cannabis regularly, they will still be able to participate
Who cannot join
- Medical contraindication to exercise or use of the nicotine patch
- Intellectual disability that would significantly impair ability to participate in the program
- Inability to give informed consent (acutely psychotic potential participants will be reassessed one month post screening
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Department of Psychiatry, Monash University, The Alfred Hospital
Melbourne, Victoria, 3004
Mental Health Research Institute, University of Melbourne, Royal Melbourne Hospital
Melbourne, Victoria, 3004
Centre for Mental Health Studies, Univeristy Of Newcastle
Newcastle, New South Wales, 2308
School of Public Health and Community Medicine, University of New South Wales
Sydney, New South Wales, 2052
About this study
This study is a feasibility study of a multi-component intervention to enhance healthy living among young people with psychotic disorders, specifically targeting smoking and weight.
Read the detailed description
We propose a feasibility study of a multi-component intervention to enhance healthy living among young people (18 to 40 years) with psychotic disorders, specifically targeting smoking and weight. Smoking is very common amongst people with psychotic disorders (around 70% of males, and over 50% of females) and this adds to the overall cardiovascular risk for this group. Obesity is also a common problem for people with psychosis, with an estimated 40-60% being obese or overweight. Obesity in this population may contribute to adverse medical and psychological consequences. For many obese people, targeted pharmacotherapy in addition to diet and increased physical activity can assist in both weight reduction and the maintenance of gains. Similarly, smoking cessation is enhanced by use of adjunctive medications such as nicotine replacement; such strategies continue to produce abstinence rates for up to 10 years.
The proposed study will assess the feasibility of a multi-component behavioural intervention focussing on smoking cessation/diet/physical activity.
The primary outcome measures from the feasibility study are smoking cessation and reduction in body mass index (BMI). Secondary outcomes will include tolerability and safety, as well as the impact the package has on other cardiovascular risk factors including serum lipids, blood sugar levels and depression in young people with psychosis. We will also establish whether smoking cessation and reduction in obesity is correlated with gains in terms of body image, quality and enjoyment of life and reduction in depression. Based on published data, behavioural interventions for smoking cessation and diet and physical activity lead smoking cessation in 20% of people at 12 months and to modest weight loss (around 5%).
- Conditions
- Psychotic Disorder, Obesity, Behavior, Addictive
- Being tested
- nicotine transdermal patch/lozenge
- Medical subject headings
- Psychotic Disorders, Obesity, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotine transdermal patch/lozengeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
Body Mass Index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startFeb 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Australian Government Department of Health and Ageing
- Investigators
- Amanda Baker, Assoc Prof, Principal investigator, Centre for Mental Health Studies, Uni of Newcastle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350311
- Sponsor's protocol ID
- 95/05
- Status last verified
- Sep 2008
- First submitted
- 6 Jul 2006
- Last updated
- 26 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Risk Factor Intervention for People With a Severe Mental Illness: a Feasibility Study
- ClinicalTrials.gov ID
- NCT00350311
- Acronym / sponsor ID
- 95/05
- Conditions
- Psychotic Disorder, Obesity, Behavior, Addictive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- Australian Government Department of Health and Ageing
- Study start
- Feb 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 10 Jul 2006 (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 is a feasibility study of a multi-component intervention to enhance healthy living among young people with psychotic disorders, specifically targeting smoking and weight.
Detailed description
We propose a feasibility study of a multi-component intervention to enhance healthy living among young people (18 to 40 years) with psychotic disorders, specifically targeting smoking and weight. Smoking is very common amongst people with psychotic disorders (around 70% of males, and over 50% of females) and this adds to the overall cardiovascular risk for this group. Obesity is also a common problem for people with psychosis, with an estimated 40-60% being obese or overweight. Obesity in this population may contribute to adverse medical and psychological consequences. For many obese people, targeted pharmacotherapy in addition to diet and increased physical activity can assist in both weight reduction and the maintenance of gains. Similarly, smoking cessation is enhanced by use of adjunctive medications such as nicotine replacement; such strategies continue to produce abstinence rates for up to 10 years.
The proposed study will assess the feasibility of a multi-component behavioural intervention focussing on smoking cessation/diet/physical activity.
The primary outcome measures from the feasibility study are smoking cessation and reduction in body mass index (BMI). Secondary outcomes will include tolerability and safety, as well as the impact the package has on other cardiovascular risk factors including serum lipids, blood sugar levels and depression in young people with psychosis. We will also establish whether smoking cessation and reduction in obesity is correlated with gains in terms of body image, quality and enjoyment of life and reduction in depression. Based on published data, behavioural interventions for smoking cessation and diet and physical activity lead smoking cessation in 20% of people at 12 months and to modest weight loss (around 5%).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-40 yrs
- DSM-IV diagnosis of non-organic psychotic illness
- Obesity (BMI > 30 or 27 if co-morbidities such as diabetes, hypertension or dyslipidaemia are present
- Current smoker ( > 15 cigarettes per day) if also smoking cannabis regularly, they will still be able to participate
Key exclusion criteria (3 listed)
- Medical contraindication to exercise or use of the nicotine patch
- Intellectual disability that would significantly impair ability to participate in the program
- Inability to give informed consent (acutely psychotic potential participants will be reassessed one month post screening
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 |
|---|---|---|
| nicotine transdermal patch/lozenge | Drug | – |
Primary outcome
Smoking Cessation
Body Mass Index
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 26 Sep 2008.
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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.
Amanda Baker, Assoc Prof principal investigator
Centre for Mental Health Studies, Uni of Newcastle
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nicotine transdermal patch/lozenge in people with Psychotic Disorder and Obesity, run by The University of New South Wales at 4 sites in Australia.
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 3 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 26 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. 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 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?
Smoking Cessation. The study lists 2 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 26 Sep 2008.