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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH050787 | U.S. NIH Grant/Contract | View source | |
| COMIRB # 04-0255 | |||
| DNBBS 73-MCR |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will examine the effects of ondansetron on auditory nerve activity in people with schizophrenia who are being treated with new antipsychotics.
Schizophrenia is a devastating brain disorder. Most people with schizophrenia have difficulty filtering out unimportant auditory information. They have an inability to appropriately inhibit, or gate, sensory information that enters the ear. Standard treatments do not address this problem. When the drug ondansetron is taken in addition to typical antipsychotic drugs, P50 auditory gating improves. However, ondansetron has not been used with some of the newer, atypical antipsychotic drugs. This study will evaluate the effect of combining ondansetron with newer, atypical antipsychotic drugs on P50 auditory gating.
Participants in this double-blind study will be randomly assigned to receive either ondansetron or placebo for 3 months. Upon completion of the first 3 months, participants will be crossed over to receive the other treatment for an additional 3 months. All participants will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or aripiprazole. Auditory gating will be assessed using computerized cognitive testing and functional magnetic resonance imaging (fMRI) at baseline and Months 3 and 6. Vital signs and evoked potentials will be assessed at Weeks 1, 3, and 6. Clinical symptoms and cognitive abilities will also be evaluated to determine the effectiveness of ondansetron.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron followed by placebo | Experimental | Participants will take ondansetron then placebo plus an atypical antipsychotic drug |
|
| Placebo followed by Ondansetron | Experimental | Participants will take placebo then ondansetron plus an atypical antipsychotic drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron followed by placebo | Drug | Participants will take 16mg of ondansetron daily for the first three months followed by 3 months of placebo. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| P50 Sensory Gating | P50 Sensory Gating as measured by evoked potentials (response to stimuli, in this case, clicking sounds).The P50 potential was identified and measured using a computer algorithm. The amplitude of the P50 test wave was divided by the amplitude of the P50 conditioning wave, expressed as a percentage: the P50 ratio. Lower P50 ratios represent better outcomes. | Up to 3 hours |
| Cognitive Testing | Measured at Months 3 and 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence E. Adler, MD | University of Colorado Health Sciences Center, VISN19 MIRECC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver VAMC | Denver | Colorado | 80220 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15677607 | Background | Adler LE, Cawthra EM, Donovan KA, Harris JG, Nagamoto HT, Olincy A, Waldo MC. Improved p50 auditory gating with ondansetron in medicated schizophrenia patients. Am J Psychiatry. 2005 Feb;162(2):386-8. doi: 10.1176/appi.ajp.162.2.386. | |
| 15465979 | Background | Adler LE, Olincy A, Cawthra EM, McRae KA, Harris JG, Nagamoto HT, Waldo MC, Hall MH, Bowles A, Woodward L, Ross RG, Freedman R. Varied effects of atypical neuroleptics on P50 auditory gating in schizophrenia patients. Am J Psychiatry. 2004 Oct;161(10):1822-8. doi: 10.1176/ajp.161.10.1822. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ondansetron Followed by Placebo | Participants will take ondansetron (16mg) at one study visit, then a placebo at another study visit one week later. |
| FG001 | Placebo Followed by Ondansetron | Participants will take a placebo at one study visit, then ondansetron (16mg) at another study visit one week later. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No information is available regarding the demographics within separate arms/groups. Multiple attempts were made to obtain results information. However, the PI has retired and the only data available is for all participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Ondansetron followed by placebo group and Placebo followed by Ondansetron group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | P50 Sensory Gating | P50 Sensory Gating as measured by evoked potentials (response to stimuli, in this case, clicking sounds).The P50 potential was identified and measured using a computer algorithm. The amplitude of the P50 test wave was divided by the amplitude of the P50 conditioning wave, expressed as a percentage: the P50 ratio. Lower P50 ratios represent better outcomes. | Posted | Mean | Standard Deviation | percentage | Up to 3 hours |
|
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No adverse events data is available. The PI has left the university and has confirmed that he no longer has access to the data, and the remaining members of the study team confirmed that the data no longer exists. Therefore, the number of participants "At risk" is 0, because no participants could be analyzed for adverse events.
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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 | Ondansetron | Ondansetron (16 mg) |
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Limited data is available. The PI has left the university and has confirmed that he no longer has access to the data, and the remaining members of the study team confirmed that the data no longer exists.
The study design was altered after registration due to a protocol amendment to not do a long-term study but to directly study participants on long-term clozapine treatment (a 5HT3 receptor antagonist like ondansetron) with other antipsychotics, including atypicals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Administration | University of Colorado Denver | 3037241111 | clinicalresearchsupportcenter@ucdenver.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
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| Placebo followed by Ondansetron | Drug | Participants will take placebo daily for the first three months followed by 3 months of 16mg of ondansetron daily. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period. |
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| 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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| Units | Counts |
|---|
| Participants |
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| Primary | Cognitive Testing | this outcome measure was not collected due to a change in the study design via a protocol amendment. | Posted | Measured at Months 3 and 6 |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Placebo | 0 | 0 | 0 | 0 |
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| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |