A Phase 2 interventional study of Merck L-830982 and Placebo in Schizophrenia, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2011-10-17.
Sponsored by University of Pittsburgh · Phase 2, Interventional, and Treatment
The purpose of this research study is to determine whether a short-term administration of an investigational study drug may provide evidence of improvement in cognitive functioning in a group of stable male subjects with schizophrenia.
The goal of this study is to determine whether the short-term (4 week), double-blind administration of Merck L-830982 provides evidence of improvement in cognitive functioning in stable male subjects with schizophrenia. This initial, small sample size study (n=9 on L-830982 and n=6 on placebo) is restricted to males in order to reduce the variance that might be attributable to the well-documented sex differences in the clinical features of schizophrenia.
3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's enrollment of 16 is below the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Drug: Merck L-830982
Drug: Placebo
The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
Also known as: MK-0777
Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
N-back Task - Reaction Time
The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.
Time frame: Week 4
N-back Task - Error Rate
The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.
Time frame: Week 4
AX Continuous Performance Test Task D-prime
For the AX Continuous Performance Test, subjects are required to maintain an attentional set across a delay interval in order to overcome a prepotent response tendency (target responses are required when an X is presented but only in the context of a preceding A; non-target conditions are AY, BX and BY). The dependent measure was d-prime at the long delay (calculated as AX hits minus BX false alarms, which is particularly sensitive to context processing impairments in individuals with schizophrenia.
Time frame: Week 4
Preparing to Overcome Prepotency (POP) Task - Reaction Time
The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.
Time frame: Week 4
Preparing to Overcome Prepotency Task - Error Rate
The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.
Time frame: Week 4
Brief Psychiatric Rating Scale Total Score
The Brief Psychiatric Rating Scale-anchored (BPRS; Overall and Gorham, 1962; Woerner, Mannuzza, Kane, 1988) is an 18-item scale that is among the most widely used measure of psychopathology. Scores range from 1-7, with higher scores reflecting greater pathology. A total score is derived from the sum of all 18 items (possible scores range from 18-126). It relies on clinical judgment in the assessment of key areas of psychopathology (depression, anxiety, psychosis).
Time frame: Week 4
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score
Five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. All subjects received the "A" form at baseline and the wk-4 visit and the "B" form at the wk-2 visit (the A/B forms are equivalent alternate forms, which allow for retesting patients without the confound of practice effects).
Time frame: Week 4
Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex
The Delayed Memory Index consists of verbal and nonverbal recall tasks (words, drawings) that the subject views early in the evaluation and without warning, is asked to recall \~1/2 hr later. Scores are expressed as standardized scores normalized to a population mean of 100, with a standard deviation of 15 (possible scores between 40-135). Higher scores reflect better performance. Subjects received the "A" form at baseline and wk-4 visit and the "B" form at the wk-2 visit (A/B forms are equivalent alternate forms, which allow for retesting patients without the confound of practice effects).
Time frame: Week 4
Participants were recruited through referrals from clinicians in the outpatient clinical services at Western Psychiatric Institute \& Clinic and through a Psychosis Registry. 29 males signed consent and 16 were eligible-one subject did not complete the study and is not included in any summary statistics. Recruitment period: 4/05 through 1/07.
| Milestone | L-830982 | Placebo |
|---|---|---|
| Started | 9 | 6 |
| Baseline, visit 1 | 9 | 6 |
| Week 1, visit 2 | 9 | 6 |
| Week 2, visit 3 | 9 | 6 |
| Week 3, visit 4 | 9 | 6 |
| Week 4, visit 5 | 9 | 6 |
| Week 5, visit 6 | 9 | 6 |
| Week 26, visit 7 | 9 | 6 |
| Year 1, visit 8 | 9 | 6 |
| Completed | 9 | 6 |
| Not completed | 0 | 0 |
The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.
| msec | L-830982 | Placebo |
|---|---|---|
| N-back Task - Reaction Time | 786 ± 231 | 684 ± 101 |
The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.
| proportion of errors | L-830982 | Placebo |
|---|---|---|
| N-back Task - Error Rate | 0.239 ± 0.062 | 0.297 ± 0.075 |
For the AX Continuous Performance Test, subjects are required to maintain an attentional set across a delay interval in order to overcome a prepotent response tendency (target responses are required when an X is presented but only in the context of a preceding A; non-target conditions are AY, BX and BY). The dependent measure was d-prime at the long delay (calculated as AX hits minus BX false alarms, which is particularly sensitive to context processing impairments in individuals with schizophrenia.
| d-prime | L-830982 | Placebo |
|---|---|---|
| AX Continuous Performance Test Task D-prime | 1.9 ± 0.9 | 0.7 ± 0.9 |
The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.
| msec | L-830982 | Placebo |
|---|---|---|
| Preparing to Overcome Prepotency (POP) Task - Reaction Time | 57 ± 66 | 66 ± 55 |
The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.
| proportion of errors | L-830982 | Placebo |
|---|---|---|
| Preparing to Overcome Prepotency Task - Error Rate | 0.042 ± 0.042 | 0.031 ± 0.074 |
The Brief Psychiatric Rating Scale-anchored (BPRS; Overall and Gorham, 1962; Woerner, Mannuzza, Kane, 1988) is an 18-item scale that is among the most widely used measure of psychopathology. Scores range from 1-7, with higher scores reflecting greater pathology. A total score is derived from the sum of all 18 items (possible scores range from 18-126). It relies on clinical judgment in the assessment of key areas of psychopathology (depression, anxiety, psychosis).
| Scores on a scale | L-830982 | Placebo |
|---|---|---|
| Brief Psychiatric Rating Scale Total Score | 26.3 ± 5.3 | 27.0 ± 3.0 |
Five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. All subjects received the "A" form at baseline and the wk-4 visit and the "B" form at the wk-2 visit (the A/B forms are equivalent alternate forms, which allow for retesting patients without the confound of practice effects).
| Standard Score | L-830982 | Placebo |
|---|---|---|
| Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score | 76.7 ± 13.5 | 70.8 ± 12.4 |
The Delayed Memory Index consists of verbal and nonverbal recall tasks (words, drawings) that the subject views early in the evaluation and without warning, is asked to recall \~1/2 hr later. Scores are expressed as standardized scores normalized to a population mean of 100, with a standard deviation of 15 (possible scores between 40-135). Higher scores reflect better performance. Subjects received the "A" form at baseline and wk-4 visit and the "B" form at the wk-2 visit (A/B forms are equivalent alternate forms, which allow for retesting patients without the confound of practice effects).
| Standard Score | L-830982 | Placebo |
|---|---|---|
| Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex | 85.3 ± 15.7 | 63.8 ± 17.6 |
Collected over Adverse event data were collected at all timepoints during the 5-week clinical trial. Eye exams were conducted at 6-month and 1-year follow-ups.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| L-830982 | — | 0/10 (0%) | 4/10 (40%) |
| Placebo | — | 0/6 (0%) | 0/6 (0%) |
| Event | L-830982 | Placebo |
|---|---|---|
| DizzinessGeneral disorders | 2/10 | 0/6 |
| SomnolenceGeneral disorders | 2/10 | 0/6 |
| Appetite increaseGeneral disorders | 1/10 | 0/6 |
| Age, Categorical(Participants) | L-830982 | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 6 | 15 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | L-830982 | Placebo | Total |
|---|---|---|---|
| Mean | 39.3 ± 10.6 | 35.7 ± 6.8 | 37.9 ± 9.2 |
| Sex: Female, Male(Participants) | L-830982 | Placebo | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 9 | 6 | 15 |
| Region of Enrollment(Participants) | L-830982 | Placebo | Total |
|---|---|---|---|
| United States | 9 | 6 | 15 |
| N-back Task Reaction Time(msec) | L-830982 | Placebo | Total |
|---|---|---|---|
| Mean | 874 ± 238 | 669 ± 158 | 801 ± 230 |
| N-back Task Error Rate(proportion of errors) | L-830982 | Placebo | Total |
|---|---|---|---|
| Mean | 0.247 ± 0.102 | 0.250 ± 0.028 | 0.248 ± 0.081 |
| AX Continuous Performance Test Task d-prime(d-prime) | L-830982 | Placebo | Total |
|---|---|---|---|
| Mean | 0.9 ± 0.7 | 0.7 ± 0.9 | 0.8 ± 0.7 |
| Preparing to Overcome Prepotency (POP) Task - Reaction Time(msec) | L-830982 | Placebo | Total |
|---|---|---|---|
| Mean | 66 ± 48 | 36 ± 61 | 54 ± 53 |
4 further baseline measures are reported on the registry.
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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