Psychotic DisordersCALMNCT01739127
Comparison of Aripiprazole Versus Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI
An observational study of Psychotic Disorders and Bipolar Disorder, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to compare abdominal weight gain and fat distribution in people taking aripiprazole versus risperidone or quetiapine, to people not taking any of these antipsychotic medications. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorders, Bipolar Disorder, Metabolic Syndrome X
- What is being tested?
- Aripiprazole and Risperidone/Quetiapine
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Feb 2016
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants who have recently been seen at a community Early Psychosis Intervention (EPI) clinic, or at BC Children's Hospital for first-episode psychosis or bipolar disorder. Age-, sex-, and weight-matched controls will be recruited from the general community.
Who may be able to join
- Male or female, aged 12+ years for healthy participants or participants with bipolar disorder; or aged 15+ years for participants with non-affective psychosis.
- Recent admission to hospital for psychiatric services related to first-episode psychosis or first-episode bipolar disorder.
- Participants being treated with an antipsychotic medication principally for psychosis or for bipolar disorder.
- Participants taking aripiprazole must be taking a dose of at least 10mg/day for the duration of the study.
- Participants must have received no more than 12 weeks of total lifetime exposure to antipsychotics.
- Participants may be in- or outpatients.
- Participants able to give informed consent, or informed consent through legally authorized representative.
Who cannot join
- Previous total lifetime exposure to antipsychotics of more than 12 weeks.
- Previously diagnosed with diabetes mellitus, seizure disorders, mental retardation (IQ < 70), or pregnancy (current or within 3 months postpartum).
- Participants who have been treated/are currently being treated with mood stabilizers (paroxetine, lithium, or valproic acid). Prior or concurrent use of Selective Serotonin Reuptake Inhibitor antidepressants (other than paroxetine) is acceptable.
- Received chemotherapy for cancer treatment in the 4 weeks prior to baseline or 16-week follow-up visit.
- Participants who are not able to fluently communicate in English.
- Contraindicated for MRI scan (i.e., has had major surgery in the last 6 months, morbid obesity, claustrophobia, and/or has metal in their bodies from a surgical intervention or working in metalwork, or is unsure if metal is present in their bodies, etc.).
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Mental Health & Addictions Research Institute
Vancouver, British Columbia, V5Z 4H4
About this study
Official title: A Longitudinal Comparison of Aripiprazole vs. Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI
The purpose of this study is to compare abdominal weight gain and fat distribution in people taking aripiprazole versus risperidone or quetiapine, to people not taking any of these antipsychotic medications.
Read the detailed description
Second generation antipsychotic drugs have much greater efficacy for refractory schizophrenia and have much lower propensity to induce motor side-effects. These medications are seeing increased use for indications other than psychosis, and greater use in populations such as adolescents. However, one of the most critical issues in the field of psychiatry today is the overwhelming evidence that chronic use of the second generation antipsychotics can result in metabolic dysregulation, which includes weight gain, hyperlipidemia, and insulin resistance. A recent meta-analysis indicated that switching from other second generation antipsychotics to the antipsychotic drug aripiprazole consistently resulted in significant weight loss and may be an optimal treatment for patients who exhibit drug-induced weight gain. Therefore, we aim to compare metabolic dysregulation (namely abdominal weight gain and fat distribution)in participants taking aripiprazole, to participants who are taking higher-metabolic propensity antipsychotic drugs (such as risperidone or quetiapine), and to healthy participants.
- Conditions
- Psychotic Disorders, Bipolar Disorder, Metabolic Syndrome X
- Being tested
- Aripiprazole, Risperidone/Quetiapine
- Keywords
- Antipsychotic agents, Adverse effects, Magnetic Resonance Imaging
- Medical subject headings
- Psychotic Disorders, Bipolar Disorder, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Also called ABILIFY
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
Risperidone/QuetiapineDrug
Also called Risperdal, Apo-risperidone, Seroquel, Apo-quetiapine
To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Participants receiving treatment with at least 10mg aripiprazole per day, as prescribed to them by their psychiatrists. Receives: Drug: Aripiprazole | |
| Risperidone/Quetiapine | Participants receiving treatment with either risperidone or quetiapine, as prescribed to them by their psychiatrists. Receives: Drug: Risperidone/Quetiapine | |
| Control | Healthy participants who are not taking any antipsychotic medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal distribution of visceral fat versus subcutaneous fat
Change over time, and between groups, in amounts of visceral and subcutaneous fat as measured by automated segmentation of a magnetic resonance image (MRI).
Measured: Baseline (within 12 weeks of starting antipsychotic treatment), and 16 weeks later
Secondary outcomes (4)
Fat content of the liver
Change over time, and between groups, in the amount of fat accumulation in the liver as measured by magnetic resonance spectroscopy (MRS).
Measured: Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later
Metabolic measures
Comparing change in the levels of hemoglobin, fasting lipid levels, adiponectin, leptin, insulin, and glucagon-like peptide 1 (GLP-1).
Measured: Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later
Glucose intolerance
Change over time, and between groups, in ability to tolerate a glucose challenge as measured by an oral glucose tolerance test (OGTT).
Measured: Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later
Potential genetic factors of antipsychotic-induced weight gain
DNA will be extracted and amplified using polymerase chain reaction (PCR), and the presence or absence of certain single nucleotide polymorphisms will be identified by using primers.
Measured: Sample to be taken after 16 weeks of participation in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Alasdair M Barr, Ph.D., Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739127
- Sponsor's protocol ID
- H12-01611
- Acronym
- CALM
- Status last verified
- May 2016
- First submitted
- 27 Nov 2012
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Comparison of Aripiprazole vs. Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI
- ClinicalTrials.gov ID
- NCT01739127
- Acronym / sponsor ID
- CALM / H12-01611
- Conditions
- Psychotic Disorders, Bipolar Disorder, Metabolic Syndrome X
- Keywords
- Antipsychotic agents, Adverse effects, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Nov 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Dec 2012 (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 compare abdominal weight gain and fat distribution in people taking aripiprazole versus risperidone or quetiapine, to people not taking any of these antipsychotic medications.
Detailed description
Second generation antipsychotic drugs have much greater efficacy for refractory schizophrenia and have much lower propensity to induce motor side-effects. These medications are seeing increased use for indications other than psychosis, and greater use in populations such as adolescents. However, one of the most critical issues in the field of psychiatry today is the overwhelming evidence that chronic use of the second generation antipsychotics can result in metabolic dysregulation, which includes weight gain, hyperlipidemia, and insulin resistance. A recent meta-analysis indicated that switching from other second generation antipsychotics to the antipsychotic drug aripiprazole consistently resulted in significant weight loss and may be an optimal treatment for patients who exhibit drug-induced weight gain. Therefore, we aim to compare metabolic dysregulation (namely abdominal weight gain and fat distribution)in participants taking aripiprazole, to participants who are taking higher-metabolic propensity antipsychotic drugs (such as risperidone or quetiapine), and to healthy participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | – | Drug: AripiprazoleParticipants receiving treatment with at least 10mg aripiprazole per day, as prescribed to them by their psychiatrists. |
| Risperidone/Quetiapine | – | Drug: Risperidone/QuetiapineParticipants receiving treatment with either risperidone or quetiapine, as prescribed to them by their psychiatrists. |
| Control | – | –Healthy participants who are not taking any antipsychotic medications. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who have recently been seen at a community Early Psychosis Intervention (EPI) clinic, or at BC Children's Hospital for first-episode psychosis or bipolar disorder. Age-, sex-, and weight-matched controls will be recruited from the general community.
Key inclusion criteria (7 listed)
- Male or female, aged 12+ years for healthy participants or participants with bipolar disorder; or aged 15+ years for participants with non-affective psychosis.
- Recent admission to hospital for psychiatric services related to first-episode psychosis or first-episode bipolar disorder.
- Participants being treated with an antipsychotic medication principally for psychosis or for bipolar disorder.
- Participants taking aripiprazole must be taking a dose of at least 10mg/day for the duration of the study.
- Participants must have received no more than 12 weeks of total lifetime exposure to antipsychotics.
Key exclusion criteria (6 listed)
- Previous total lifetime exposure to antipsychotics of more than 12 weeks.
- Previously diagnosed with diabetes mellitus, seizure disorders, mental retardation (IQ < 70), or pregnancy (current or within 3 months postpartum).
- Participants who have been treated/are currently being treated with mood stabilizers (paroxetine, lithium, or valproic acid). Prior or concurrent use of Selective Serotonin Reuptake Inhibitor antidepressants (other than paroxetine) is acceptable.
- Received chemotherapy for cancer treatment in the 4 weeks prior to baseline or 16-week follow-up visit.
- Participants who are not able to fluently communicate in English.
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 |
|---|---|---|
| AripiprazoleAlso: ABILIFYTo be prescribed and monitored by participant's attending physician (not given to participants as a part of the study). | Drug | Aripiprazole |
| Risperidone/QuetiapineAlso: Risperdal, Apo-risperidone, Seroquel, Apo-quetiapineTo be prescribed and monitored by participant's attending physician (not given to participants as a part of the study). | Drug | Risperidone/Quetiapine |
Primary outcome
Abdominal distribution of visceral fat versus subcutaneous fat
Time frame: Baseline (within 12 weeks of starting antipsychotic treatment), and 16 weeks later
Change over time, and between groups, in amounts of visceral and subcutaneous fat as measured by automated segmentation of a magnetic resonance image (MRI).
4 secondary outcomes
Fat content of the liver
Time frame: Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later
Metabolic measures
Time frame: Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later
Glucose intolerance
Time frame: Baseline (within 12 weeks of starting an antipsychotic), and 16 weeks later
Potential genetic factors of antipsychotic-induced weight gain
Time frame: Sample to be taken after 16 weeks of participation in the study
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 25 May 2016.
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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.
Alasdair M Barr, Ph.D. principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorders and Bipolar Disorder, run by University of British Columbia at 1 site in Canada.
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 7 inclusion and 6 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 25 May 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 Canada. 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.
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?
Abdominal distribution of visceral fat versus subcutaneous fat (time frame: Baseline (within 12 weeks of starting antipsychotic treatment), and 16 weeks later). 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 25 May 2016.