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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH059312 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.
Over the past several years, new, "atypical" antipsychotic medications have become available to treat schizophrenia with little information to guide prescribing for relatively stable outpatients.
Participants will be randomly assigned to either continue taking their current medications for schizophrenia, or to switch to a new medication. Participants assigned to switch to a new medication will begin receiving either olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), quetiapine (Seroquel), or aripiprazole (Abilify), depending on what they are currently taking. Participants currently taking a single oral medication will switch to olanzapine, risperidone, ziprasidone, quetiapine, or aripiprazole. Participants currently taking a single conventional injectable will begin taking long-acting injectable risperidone (Risperdal Consta). Participants currently taking two antipsychotic medications will begin taking only one of the medications they are currently using. Participants will stay on their assigned treatment for 6 months, after which time the participant's prescribing psychiatrist will advise the participant on which medication should be used. Study participants are interviewed at study start and at follow-up visits for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stay on baseline medication prescribed | Active Comparator | Participants will continue taking medication prescribed at study entry: 1) either long-acting injectable haloperidol or fluphenazine, OR 2) two antipsychotic medications which might include a combination of any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications. |
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| Switch per study protocol | Active Comparator | Participants will change medications from medication prescribed at study entry, either: 1) long-acting injectable risperidone, OR 2) one of the two antipsychotic medications prescribed at baseline which may include any of the following: risperidone, olanzapine, ziprasidone, quetiapine, aripiprazole, or conventional (typical) antipsychotic medications. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | As prescribed by routine prescriber (not dictated by study protocol) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number Who Discontinued Medication Within First 6 Study Months | Measured at Six Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Hospitalized | Number of participants hospitalized for psychiatric reasons | during first 6 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan M. Essock, PhD | Columbia University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22480442 | Result | Covell NH, McEvoy JP, Schooler NR, Stroup TS, Jackson CT, Rojas IA, Essock SM; Schizophrenia Trials Network. Effectiveness of switching from long-acting injectable fluphenazine or haloperidol decanoate to long-acting injectable risperidone microspheres: an open-label, randomized controlled trial. J Clin Psychiatry. 2012 May;73(5):669-75. doi: 10.4088/JCP.11m07074. Epub 2012 Mar 6. | |
| 21536693 | Result | Essock SM, Schooler NR, Stroup TS, McEvoy JP, Rojas I, Jackson C, Covell NH; Schizophrenia Trials Network. Effectiveness of switching from antipsychotic polypharmacy to monotherapy. Am J Psychiatry. 2011 Jul;168(7):702-8. doi: 10.1176/appi.ajp.2011.10060908. Epub 2011 May 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stay | Participants will continue taking medication prescribed at study entry |
| FG001 | Switch | Participants will change medications from medication prescribed at study entry |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stay | Participants will continue taking medication prescribed at study entry |
| BG001 | Switch | Participants will change medications from medication prescribed at study entry |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number Who Discontinued Medication Within First 6 Study Months | intent to treat samples for 2 substudies: injectable to injectable and polypharmacy to monotherapy | Posted | Number | participants | Measured at Six Months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stay | Participants will continue taking medication prescribed at study entry |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric Hospitalization | Psychiatric disorders | Systematic Assessment | Following medication change, participant's prescriber called Project Director to report that the participant was not doing well and was hospitalized subsequent to symptom exacerbation; prescriber changed client's antipsychotic medication regime. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy H. Covell, Ph.D. | NYSPI | 6469450227 | covelln@nyspi.columbia.edu |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| D000077152 | Olanzapine |
| C092292 | ziprasidone |
| D000069348 | Quetiapine Fumarate |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Olanzapine | Drug | As prescribed by routine prescriber (not dictated by study protocol) |
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| Ziprasidone | Drug | As prescribed by routine prescriber (not dictated by study protocol) |
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| Quetiapine | Drug | As prescribed by routine prescriber (not dictated by study protocol) |
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| Aripiprazole | Drug | As prescribed by routine prescriber (not dictated by study protocol) |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Number of Participants Hospitalized | Number of participants hospitalized for psychiatric reasons | Posted | Count of Participants | Participants | during first 6 months |
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| 0 |
| 102 |
| 0 |
| 102 |
| EG001 | Switch | Participants will change medications from medication prescribed at study entry | 2 | 117 | 0 | 117 |
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| Death | Cardiac disorders | Systematic Assessment | Site PI learned that the 69 year old participant had died following recurrent episodes of bleeding from cerebral aneurism that was diagnosed, but unknown to the site PI, prior to study enrollment (randomized to injectable risperidone) |
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| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D010879 | Piperazines |
| D015363 | Quinolones |
| D011804 | Quinolines |