SchizophreniaNCT00493233
Antipsychotic Polypharmacy in Schizophrenia
A study testing 2 antipsychotic medications (combinations of olanzapine, risperidone, clozapine, seroquel, haldol, perphenazine) in people with Schizophrenia, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The literature suggests that when a patient is prescribed more than one antipsychotic for at least 30 days, he or she is likely to continue on that combination. In this 12 week study 100 adult patients being treated on more than one antipsychotic medication for at least 30 days will be recruited. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- 2 antipsychotic medications (combinations of olanzapine, risperidone, clozapine, seroquel, haldol, perphenazine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2006to Dec 2008
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥ 18 years
- Suffering from a primary psychotic disorder (confirmed using the MINI International Neuropsychiatric Interview for DSM-IV (Version 5.0.0)
- Treated with two antipsychotic drugs for at least 30 days (excluding "prn" or "as needed" antipsychotic prescriptions)
Who cannot join
- A history of treatment with a depot antipsychotic within 6-months of enrollment will be excluded form the study unless the depot antipsychotic is considered the "main" antipsychotic drug in this study
Trial locations and contacts
1 site in 1 country.
About this study
The literature suggests that when a patient is prescribed more than one antipsychotic for at least 30 days, he or she is likely to continue on that combination. In this 12 week study 100 adult patients being treated on more than one antipsychotic medication for at least 30 days will be recruited. In order to control for the natural course of the illness, patients will be randomly assigned to one of two groups: the first group will continue the second medication hidden in a capsule at the same dose, while the second group will be given an inactive capsule (placebo) - the capsules in both group will be identical such that neither the patient nor the treating doctor will be able to identify the group assignment.
Read the detailed description
There is no evidence that using more than one antipsychotic drug enhances clinical efficacy. Nonetheless, this practice is highly prevalent (up to 1/3 of our patient population), and physicians are reluctant to reduce patients' treatment to a single antipsychotic drug for fear of precipitating relapse. This study therefore seeks to evaluate the effectiveness of continued treatment with more than one antipsychotic drug using a rigorous placebo-controlled design. The results of this study will subsequently serve to guide physicians in making appropriately informed decisions regarding the continuation of multiple antipsychotic drugs.
Our primary hypothesis is that we expect to find no difference in the primary variable of interest (BPRS) following reduction to antipsychotic monotherapy (placebo group) versus continuing antipsychotic polypharmacy.
This proposed study is the first study to systematically address the reduction of antipsychotic polypharmacy to monotherapy in patients with primary psychotic disorders in a prospective, double-blind, placebo-controlled design. The results of this study will have important implications for the clinical practice of physicians treating the severely mentally ill who are often constrained to practice beyond the limits of available clinical guidelines and evidence based medicine. Thus, in light of the high and growing prevalence of this practice, the proposed study speaks to a real and practical clinical dilemma within this field. Furthermore, as a university-based, tertiary care psychiatric centre serving thousands of severely ill patients suffering from primary psychotic disorders and with an established track record for innovative clinical research, we are uniquely placed to address these critical questions.
Male or female subjects aged ≥ 18 years suffering from a primary psychotic disorder treated with two antipsychotic drugs for at least 30 days (excluding "prn" or "as needed" antipsychotic prescriptions) will be eligible to participate in this study. Subjects with a history of treatment with a depot antipsychotic within 6-months of enrollment will be excluded form the study unless the depot antipsychotic is considered the "main" antipsychotic drug in this study. The "main" antipsychotic drug will be determined by the treating physician, except for the case of clozapine which will be considered the 'main' antipsychotic. Eligible subjects will be randomly allocated to two groups: Group 1 will continue taking the concomitant antipsychotic drug; Group 2 will be allocated to placebo in place of the concomitant antipsychotic drug. The dose of the "main" antipsychotic drug will remain open and flexible at the discretion of the attending physician. The dose of the "second" antipsychotic drug will remain fixed throughout the study period.
- Conditions
- Schizophrenia
- Being tested
- 2 antipsychotic medications (combinations of olanzapine, risperidone, clozapine, seroquel, haldol, perphenazine), main antipsychotic medication and placebo
- Keywords
- schizophrenia, antipsychotics, polypharmacy, double-blind, randomized
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 antipsychotic medications (combinations of olanzapine, risperidone, clozapine, seroquel, haldol, perphenazine)Drug
Primary antipsychotic medication (olanzapine, oral risperidone, seroquel, clozapine, haldol, perphenazine) will be determined by the treating physician and participants will continue taking the concomitant antipsychotic drug. The dose of the main antipsychotic drug will remain open and flexible at the discretion of the attending physician. The dose of the "second" antipsychotic drug will remain fixed throughout the study period.
main antipsychotic medication and placeboDrug
The "main" antipsychotic drug will be determined by the treating physician. Participants will be allocated to placebo in place of the concomitant antipsychotic drug. The dose of the "main" antipsychotic drug will remain open and flexible at the discretion of the attending physician.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: 2 antipsychotic medications (combinations of olanzapine, risperidone, clozapine, seroquel, haldol, perphenazine) |
| 2 | Placebo comparator | Not described Receives: Drug: main antipsychotic medication and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Psychiatric Rating Scale (BPRS)
Measured: intermittent
Clinical Global Impression Scale
Measured: intermittent
Secondary outcomes (2)
Barned Akathisia Scale
Measured: intermittent
Simpson-Angus Scale (SAS)
Measured: intermittent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startNov 2006
- Primary completionDec 2008
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 SchizophreniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Psychiatric Research Foundation
- Investigators
- David Mamo, MD, MSc, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493233
- Sponsor's protocol ID
- 174/2006
- Status last verified
- May 2009
- First submitted
- 4 Jun 2007
- Last updated
- 19 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Borlido C, Remington G, Graff-Guerrero A, Arenovich T, Hazra M, Wong A, Daskalakis ZJ, Mamo DC. Switching from 2 antipsychotics to 1 antipsychotic in schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2016 Jan;77(1):e14-20. doi: 10.4088/JCP.14m09321.
PubMed 26845273
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antipsychotic Polypharmacy in Schizophrenia
- ClinicalTrials.gov ID
- NCT00493233
- Acronym / sponsor ID
- 174/2006
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, antipsychotics, polypharmacy, double-blind, randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Psychiatric Research Foundation
- Study start
- Nov 2006
- Primary completion
- Dec 2008 (actual)
- First posted
- 28 Jun 2007 (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 literature suggests that when a patient is prescribed more than one antipsychotic for at least 30 days, he or she is likely to continue on that combination. In this 12 week study 100 adult patients being treated on more than one antipsychotic medication for at least 30 days will be recruited. In order to control for the natural course of the illness, patients will be randomly assigned to one of two groups: the first group will continue the second medication hidden in a capsule at the same dose, while the second group will be given an inactive capsule (placebo) - the capsules in both group will be identical such that neither the patient nor the treating doctor will be able to identify the group assignment.
Detailed description
There is no evidence that using more than one antipsychotic drug enhances clinical efficacy. Nonetheless, this practice is highly prevalent (up to 1/3 of our patient population), and physicians are reluctant to reduce patients' treatment to a single antipsychotic drug for fear of precipitating relapse. This study therefore seeks to evaluate the effectiveness of continued treatment with more than one antipsychotic drug using a rigorous placebo-controlled design. The results of this study will subsequently serve to guide physicians in making appropriately informed decisions regarding the continuation of multiple antipsychotic drugs.
Our primary hypothesis is that we expect to find no difference in the primary variable of interest (BPRS) following reduction to antipsychotic monotherapy (placebo group) versus continuing antipsychotic polypharmacy.
This proposed study is the first study to systematically address the reduction of antipsychotic polypharmacy to monotherapy in patients with primary psychotic disorders in a prospective, double-blind, placebo-controlled design. The results of this study will have important implications for the clinical practice of physicians treating the severely mentally ill who are often constrained to practice beyond the limits of available clinical guidelines and evidence based medicine. Thus, in light of the high and growing prevalence of this practice, the proposed study speaks to a real and practical clinical dilemma within this field. Furthermore, as a university-based, tertiary care psychiatric centre serving thousands of severely ill patients suffering from primary psychotic disorders and with an established track record for innovative clinical research, we are uniquely placed to address these critical questions.
Male or female subjects aged ≥ 18 years suffering from a primary psychotic disorder treated with two antipsychotic drugs for at least 30 days (excluding "prn" or "as needed" antipsychotic prescriptions) will be eligible to participate in this study. Subjects with a history of treatment with a depot antipsychotic within 6-months of enrollment will be excluded form the study unless the depot antipsychotic is considered the "main" antipsychotic drug in this study. The "main" antipsychotic drug will be determined by the treating physician, except for the case of clozapine which will be considered the 'main' antipsychotic. Eligible subjects will be randomly allocated to two groups: Group 1 will continue taking the concomitant antipsychotic drug; Group 2 will be allocated to placebo in place of the concomitant antipsychotic drug. The dose of the "main" antipsychotic drug will remain open and flexible at the discretion of the attending physician. The dose of the "second" antipsychotic drug will remain fixed throughout the study period.
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: 2 antipsychotic medications (combinations of olanzapine, risperidone, clozapine, seroquel, haldol, perphenazine) |
| 2 | Placebo comparator | Drug: main antipsychotic medication and placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects aged ≥ 18 years
- Suffering from a primary psychotic disorder (confirmed using the MINI International Neuropsychiatric Interview for DSM-IV (Version 5.0.0)
- Treated with two antipsychotic drugs for at least 30 days (excluding "prn" or "as needed" antipsychotic prescriptions)
Key exclusion criteria (1 listed)
- A history of treatment with a depot antipsychotic within 6-months of enrollment will be excluded form the study unless the depot antipsychotic is considered the "main" antipsychotic drug in this study
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 |
|---|---|---|
| 2 antipsychotic medications (combinations of olanzapine, risperidone, clozapine, seroquel, haldol, perphenazine)Primary antipsychotic medication (olanzapine, oral risperidone, seroquel, clozapine, haldol, perphenazine) will be determined by the treating physician and participants will continue taking the concomitant antipsychotic drug. The dose of the main antipsychotic drug will remain open and flexible at the discretion of the attending physician. The dose of the "second" antipsychotic drug will remain fixed throughout the study period. | Drug | 1 |
| main antipsychotic medication and placeboThe "main" antipsychotic drug will be determined by the treating physician. Participants will be allocated to placebo in place of the concomitant antipsychotic drug. The dose of the "main" antipsychotic drug will remain open and flexible at the discretion of the attending physician. | Drug | 2 |
Primary outcome
Brief Psychiatric Rating Scale (BPRS)
Time frame: intermittent
Clinical Global Impression Scale
Time frame: intermittent
2 secondary outcomes
Barned Akathisia Scale
Time frame: intermittent
Simpson-Angus Scale (SAS)
Time frame: intermittent
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 19 May 2009.
- Derived from this study: PubMed 26845273Borlido C, Remington G, Graff-Guerrero A, Arenovich T, Hazra M, Wong A, Daskalakis ZJ, Mamo DC. Switching from 2 antipsychotics to 1 antipsychotic in schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2016 Jan;77(1):e14-20. doi: 10.4088/JCP.14m09321.
- Information about research at the Centre for Addiction and Mental Health (CAMH)Link provided by the sponsor.
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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.
David Mamo, MD, MSc principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 antipsychotic medications (combinations of olanzapine, risperidone, clozapine, seroquel, haldol, perphenazine) in people with Schizophrenia, run by Centre for Addiction and Mental Health 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 3 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 19 May 2009. 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. 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.
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?
Brief Psychiatric Rating Scale (BPRS) (time frame: intermittent). 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?
On the ClinicalTrials.gov record for NCT00493233, 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 19 May 2009.