SchizophreniaMOPENCT01368458
Conversion to Antipsychotic Monotherapy
A study testing Conversion to Antipsychotic Monotherapy in people with Schizophrenia and Schizoaffective Disorder, run by Nathan Kline Institute for Psychiatric Research.
Trial summary
This is a 12-week, with a 32-week follow-up, rater-blind, randomized controlled trial to determine whether patients with chronic schizophrenia or schizoaffective disorder receiving two different antipsychotics simultaneously will have any significant change in psychopathology following conversion to antipsychotic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Conversion to Antipsychotic Monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Jul 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-64 with a SCID DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder, confirmed by SCID, who are able to give written informed consent and on stable dosages of two antipsychotics for at least one month prior to baseline.
Who cannot join
- Lack of capacity to give informed consent (capacity is determined by a licensed member of the treatment team)
- unstable medical illness
- use of long acting injectable preparations of antipsychotic medication in the previous two months
- documented failure of previous dose reduction
- current treatment with clozapine
- addition of any new psychotropic in the previous month
- patients who are severely assaultive and in clinical need of more than one antipsychotic for their safe management
About this study
Official title: A Randomized, Rater-Blind, Controlled, Clinical Trial of Conversion to Antipsychotic Monotherapy vs. Continued Polypharmacy for Patients With Schizophrenia or Schizoaffective Disorder
This is a 12-week, with a 32-week follow-up, rater-blind, randomized controlled trial to determine whether patients with chronic schizophrenia or schizoaffective disorder receiving two different antipsychotics simultaneously will have any significant change in psychopathology following conversion to antipsychotic monotherapy. Additionally, the effects of conversion to antipsychotic monotherapy will be assessed by neurocognitive tests.
The study will be conducted at the Clinical Research and Evaluation Facility (CREF), a specialized research unit jointly operated by the Nathan S Kline Institute for Psychiatric Research (NKI) and Rockland Psychiatric Center (RPC). Patients will be recruited from the regular in-patient units of RPC and transferred to the CREF. Following baseline assessments, patients will be randomized to continued antipsychotic polypharmacy treatment or to systematic conversion to monotherapy.
Conversion to antipsychotic monotherapy will be assessed across multiple domains of psychopathology using the Positive and Negative Symptom Scale (PANSS). The primary outcome measure is PANSS total score. The secondary outcome measure is time on medication (all-cause dropouts). Mixed Model Repeated Measures (MMRM) will test the hypothesis that conversion to antipsychotic monotherapy will show minimal change from the control group.
Read the detailed description
Background:
Often, treatment resistant schizophrenia patients are treated with high doses of, or polypharmacy with, antipsychotics, or both. There is a lack of systematic evidence for either practice, and this is not recommended by most treatment guidelines. Often polypharmacy results in dosages well above the recommended upper limit of dosage. Recent studies of antipsychotic utilization, have reported that approximately 10-60% of patients are prescribed at least two antipsychotics.
Moreover, antipsychotic treatment carries substantial risks, including the potential development of tardive dyskinesia or metabolic syndrome. Higher doses may expose patients to more adverse events or consequences without any additional therapeutic benefit. Clear benefits of long-term treatment with antipsychotic polypharmacy have rarely been reported, and there is a void of long term double blind, placebo controlled trials.
Antipsychotic polypharmacy remains common, including patients receiving atypical antipsychotics. To our knowledge, no one has published a study of a systematic, randomized controlled conversion to antipsychotic monotherapy for patients with chronic schizophrenia or schizoaffective disorder receiving atypical antipsychotic polypharmacy.
Design:
Hospitalized patients with DSM-IV-TR schizophrenia or schizoaffective disorder meeting the following criteria: (1) at least two antipsychotics, (2) stable dosages for at least one month prior to baseline, (3) baseline dosages of at least one of the antipsychotics are at least olanzapine 15 mg, ziprasidone 120 mg, quetiapine 500 mg, risperidone 4 mg, aripiprazole 10 mg, paliperidone 6 mg, any dose of clozapine, or any first generation antipsychotic >300 chlorpromazine equivalents.
After a baseline assessment, patients will be randomized to conversion to antipsychotic monotherapy of one of their two antipsychotics or continued on their combination antipsychotic treatment. Other psychotropics will be left unchanged from baseline, and the prescription of a new psychotropic will not be permitted, excepting lorazepam and benztropine as detailed below.
If a patient is randomized to conversion to monotherapy, then the decision of which of the two baseline antipsychotics to continue will occur as follows:
- If one is clozapine, then clozapine will be continued.
- In all other cases:
- If only one of the antipsychotics is at a dose greater than the above noted doses, then that is one that will be continued.
- If both doses are greater than the above noted doses, then there will be a flip of a coin to determine which to continue, with heads equal the one with the higher alphabetic letter and tails equal to the lower.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Conversion to Antipsychotic Monotherapy
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversion to Antipsychotic MonotherapyOther
Patients assigned to the antipsychotic monotherapy group will have the dosage of their secondary (i.e. one due to be reduced) antipsychotic reduced by decreased by approximately 1/3 every 3 weeks. Dosage of the primary antipsychotic will be left unchanged.
| Study group | Role | What they receive |
|---|---|---|
| Conversion to mono therapy | Experimental | Conversion from 2 to 1 antipsychotic Receives: Other: Conversion to Antipsychotic Monotherapy |
| control | No intervention | No change in antipsychotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptom Scale (PANSS) total score
Measured: 12 weeks
Relapse Rate
Measured: 12 weeks
Secondary outcomes (8)
Nurses Observation Scale for Inpatient Evaluation (NOSIE)
Measured: 12 weeks
Abnormal Involuntary Movement Scale (AIMS)
Measured: 12 weeks
Simpson-Angus Scale (SAS)
Measured: 12 weeks
Barnes Akathisia Scale
Measured: 12 weeks
MATRICS
Measured: 12 weeks
Clinical Global Impression (CGI)
Measured: 12 weeks
Weight
Measured: 12 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startDec 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nathan Kline Institute for Psychiatric Research
- Sponsor type
- University, hospital or other
- Investigators
- Joshua Kantrowitz, MD, Principal investigator, Nathan Kline Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368458
- Sponsor's protocol ID
- 07I/C31
- Acronym
- MOPE
- Status last verified
- Feb 2017
- First submitted
- 1 Jul 2008
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Rater-Blind, Controlled, Clinical Trial of Conversion to Antipsychotic Monotherapy vs. Continued Polypharmacy for Patients With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT01368458
- Acronym / sponsor ID
- MOPE / 07I/C31
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nathan Kline Institute for Psychiatric ResearchUniversity, hospital or other
- Study start
- Dec 2007
- Study completion
- Jul 2008 (actual)
- First posted
- 8 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.
This is a 12-week, with a 32-week follow-up, rater-blind, randomized controlled trial to determine whether patients with chronic schizophrenia or schizoaffective disorder receiving two different antipsychotics simultaneously will have any significant change in psychopathology following conversion to antipsychotic monotherapy. Additionally, the effects of conversion to antipsychotic monotherapy will be assessed by neurocognitive tests.
The study will be conducted at the Clinical Research and Evaluation Facility (CREF), a specialized research unit jointly operated by the Nathan S Kline Institute for Psychiatric Research (NKI) and Rockland Psychiatric Center (RPC). Patients will be recruited from the regular in-patient units of RPC and transferred to the CREF. Following baseline assessments, patients will be randomized to continued antipsychotic polypharmacy treatment or to systematic conversion to monotherapy.
Conversion to antipsychotic monotherapy will be assessed across multiple domains of psychopathology using the Positive and Negative Symptom Scale (PANSS). The primary outcome measure is PANSS total score. The secondary outcome measure is time on medication (all-cause dropouts). Mixed Model Repeated Measures (MMRM) will test the hypothesis that conversion to antipsychotic monotherapy will show minimal change from the control group.
Detailed description
Background:
Often, treatment resistant schizophrenia patients are treated with high doses of, or polypharmacy with, antipsychotics, or both. There is a lack of systematic evidence for either practice, and this is not recommended by most treatment guidelines. Often polypharmacy results in dosages well above the recommended upper limit of dosage. Recent studies of antipsychotic utilization, have reported that approximately 10-60% of patients are prescribed at least two antipsychotics.
Moreover, antipsychotic treatment carries substantial risks, including the potential development of tardive dyskinesia or metabolic syndrome. Higher doses may expose patients to more adverse events or consequences without any additional therapeutic benefit. Clear benefits of long-term treatment with antipsychotic polypharmacy have rarely been reported, and there is a void of long term double blind, placebo controlled trials.
Antipsychotic polypharmacy remains common, including patients receiving atypical antipsychotics. To our knowledge, no one has published a study of a systematic, randomized controlled conversion to antipsychotic monotherapy for patients with chronic schizophrenia or schizoaffective disorder receiving atypical antipsychotic polypharmacy.
Design:
Hospitalized patients with DSM-IV-TR schizophrenia or schizoaffective disorder meeting the following criteria: (1) at least two antipsychotics, (2) stable dosages for at least one month prior to baseline, (3) baseline dosages of at least one of the antipsychotics are at least olanzapine 15 mg, ziprasidone 120 mg, quetiapine 500 mg, risperidone 4 mg, aripiprazole 10 mg, paliperidone 6 mg, any dose of clozapine, or any first generation antipsychotic >300 chlorpromazine equivalents.
After a baseline assessment, patients will be randomized to conversion to antipsychotic monotherapy of one of their two antipsychotics or continued on their combination antipsychotic treatment. Other psychotropics will be left unchanged from baseline, and the prescription of a new psychotropic will not be permitted, excepting lorazepam and benztropine as detailed below.
If a patient is randomized to conversion to monotherapy, then the decision of which of the two baseline antipsychotics to continue will occur as follows:
- If one is clozapine, then clozapine will be continued.
- In all other cases:
- If only one of the antipsychotics is at a dose greater than the above noted doses, then that is one that will be continued.
- If both doses are greater than the above noted doses, then there will be a flip of a coin to determine which to continue, with heads equal the one with the higher alphabetic letter and tails equal to the lower.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conversion to mono therapy | Experimental | Other: Conversion to Antipsychotic MonotherapyConversion from 2 to 1 antipsychotic |
| control | No intervention | –No change in antipsychotics |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-64 with a SCID DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder, confirmed by SCID, who are able to give written informed consent and on stable dosages of two antipsychotics for at least one month prior to baseline.
Key exclusion criteria (7 listed)
- Lack of capacity to give informed consent (capacity is determined by a licensed member of the treatment team)
- unstable medical illness
- use of long acting injectable preparations of antipsychotic medication in the previous two months
- documented failure of previous dose reduction
- current treatment with clozapine
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 |
|---|---|---|
| Conversion to Antipsychotic MonotherapyPatients assigned to the antipsychotic monotherapy group will have the dosage of their secondary (i.e. one due to be reduced) antipsychotic reduced by decreased by approximately 1/3 every 3 weeks. Dosage of the primary antipsychotic will be left unchanged. | Other | Conversion to mono therapy |
Primary outcome
Positive and Negative Symptom Scale (PANSS) total score
Time frame: 12 weeks
Relapse Rate
Time frame: 12 weeks
8 secondary outcomes
Nurses Observation Scale for Inpatient Evaluation (NOSIE)
Time frame: 12 weeks
Abnormal Involuntary Movement Scale (AIMS)
Time frame: 12 weeks
Simpson-Angus Scale (SAS)
Time frame: 12 weeks
Barnes Akathisia Scale
Time frame: 12 weeks
MATRICS
Time frame: 12 weeks
Clinical Global Impression (CGI)
Time frame: 12 weeks
Weight
Time frame: 12 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
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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.
Joshua Kantrowitz, MD principal investigator
Nathan Kline Institute
Questions about this trial
What is this clinical trial studying?
A study testing Conversion to Antipsychotic Monotherapy in people with Schizophrenia and Schizoaffective Disorder, run by Nathan Kline Institute for Psychiatric Research.
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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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?
Positive and Negative Symptom Scale (PANSS) total score (time frame: 12 weeks). 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 9 Feb 2017.