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Gamma-Amino Butyric Acid (GABA)-A Alpha2/3 Study

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ClinicalTrials.gov Identifier: NCT00129441
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : October 17, 2011
Last Update Posted : October 17, 2011
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Pittsburgh

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Merck L-830982
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
To ensure eligibility before randomization, the following were administered: a urine drug screen; diagnostic, medical history and adverse events ratings; Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); electrocardiogram; blood tests (for kidney and liver function); and a complete eye exam, including a slit-lamp exam.

Reporting Groups
  Description
L-830982 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.
Placebo Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.

Participant Flow:   Overall Study
    L-830982   Placebo
STARTED   9   6 
Baseline, Visit 1   9 [1]   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 
[1] Baseline # only includes those who completed 4-week trial (one L-830982 subject did not complete).



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
L-830982 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.
Placebo Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
Total Total of all reporting groups

Baseline Measures
   L-830982   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 9   6   15 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   9   6   15 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 39.3  (10.6)   35.7  (6.8)   37.9  (9.2) 
Gender 
[Units: Participants]
 		     
Female   0   0   0 
Male   9   6   15 
Region of Enrollment 
[Units: Participants]
 		     
United States   9   6   15 
N-back Task Reaction Time [1] 
[Units: Msec]
Mean (Standard Deviation) 		 874  (238)   669  (158)   801  (230) 
[1] 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. Those with schizophrenia exhibit substantially impaired performance and decreased functional activation of the dorsolateral prefrontal cortex (DLPFC) relative to matched comparison subjects for the 2-back load condition. 2-back condition was used as the dependent measure, as it provides the best index of performance and DLPFC disturbances in subjects with schizophrenia.
N-back Task Error Rate [1] 
[Units: Proportion of errors]
Mean (Standard Deviation) 		 0.247  (0.102)   0.250  (0.028)   0.248  (0.081) 
[1] 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. Those with schizophrenia exhibit substantially impaired performance and decreased functional activation of the dorsolateral prefrontal cortex (DLPFC) relative to matched comparison subjects for the 2-back load condition. 2-back condition was used as the dependent measure, as it provides the best index of performance and DLPFC disturbances in subjects with schizophrenia.
AX Continuous Performance Test Task d-prime [1] 
[Units: D-prime]
Mean (Standard Deviation) 		 0.9  (0.7)   0.7  (0.9)   0.8  (0.7) 
[1] For the AX Continuous Performance Test (AXCPT), 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.
Preparing to Overcome Prepotency (POP) Task - Reaction Time [1] 
[Units: Msec]
Mean (Standard Deviation) 		 66  (48)   36  (61)   54  (53) 
[1] 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.
Preparing to Overcome Prepotency (POP) Task - Error Rate [1] 
[Units: Proportion of errors]
Mean (Standard Deviation) 		 0.034  (0.050)   0.064  (0.068)   0.046  (0.058) 
[1] 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.
Brief Psychiatric Rating Scale (BPRS) Total Score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation) 		 24.3  (2.6)   34.2  (7.1)   28.3  (6.9) 
[1] 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).
Repeatable Battery for the Assessment of Neuropsychological Status: RBANS Total Score [1] 
[Units: Standard Score]
Mean (Standard Deviation) 		 71.8  (10.6)   63.5  (7.1)   68.5  (10.0) 
[1] 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).
Repeatable Battery for the Assessment of Neuropsychological Status: RBANS Delayed Memory Subindex [1] 
[Units: Standard Score]
Mean (Standard Deviation) 		 76.8  (15.5)   60.8  (16.1)   70.4  (17.2) 
[1] 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).


  Outcome Measures

1.  Primary:   N-back Task - Reaction Time   [ Time Frame: Week 4 ]

Measure Type Primary
Measure Title N-back Task - Reaction Time
Measure Description 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analyses included only those participants who completed the 4-week trial. One participant refused N-back at week-4, so 9 L-830982 and 5 placebo were analyzed.

Reporting Groups
  Description
L-830982 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.
Placebo Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.

Measured Values
   L-830982   Placebo 
Participants Analyzed 
[Units: Participants]
 		 9   5 
N-back Task - Reaction Time 
[Units: Msec]
Mean (Standard Deviation) 		 786  (231)   684  (101) 


Statistical Analysis 1 for N-back Task - Reaction Time
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] 0.16
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Primary:   N-back Task - Error Rate   [ Time Frame: Week 4 ]

Measure Type Primary
Measure Title N-back Task - Error Rate
Measure Description 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analyses included only those participants who completed the 4-week trial. One participant refused N-back at week-4, so 9 L-830982 and 5 placebo were analyzed.

Reporting Groups
  Description
L-830982 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.
Placebo Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.

Measured Values
   L-830982   Placebo 
Participants Analyzed 
[Units: Participants]
 		 9   5 
N-back Task - Error Rate 
[Units: Proportion of errors]
Mean (Standard Deviation) 		 0.239  (0.062)   0.297  (0.075) 


Statistical Analysis 1 for N-back Task - Error Rate
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] 0.162
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Primary:   AX Continuous Performance Test Task D-prime   [ Time Frame: Week 4 ]

Measure Type Primary
Measure Title AX Continuous Performance Test Task D-prime
Measure Description 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Four subjects did not complete a sufficient number of trials for the AXCPT task at both testing periods, therefore 7 L-830982 and 4 placebo subjects data were analyzed.

Reporting Groups
  Description
L-830982 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.
Placebo Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.

Measured Values
   L-830982   Placebo 
Participants Analyzed 
[Units: Participants]
 		 7   4 
AX Continuous Performance Test Task D-prime 
[Units: D-prime]
Mean (Standard Deviation) 		 1.9  (0.9)   0.7  (0.9) 


Statistical Analysis 1 for AX Continuous Performance Test Task D-prime
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] 0.12
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



4.  Primary:   Preparing to Overcome Prepotency (POP) Task - Reaction Time   [ Time Frame: Week 4 ]

Measure Type Primary
Measure Title Preparing to Overcome Prepotency (POP) Task - Reaction Time
Measure Description 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
L-830982 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.
Placebo Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.

Measured Values
   L-830982   Placebo 
Participants Analyzed 
[Units: Participants]
 		 9   6 
Preparing to Overcome Prepotency (POP) Task - Reaction Time 
[Units: Msec]
Mean (Standard Deviation) 		 57  (66)   66  (55) 


Statistical Analysis 1 for Preparing to Overcome Prepotency (POP) Task - Reaction Time
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] 0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Primary:   Preparing to Overcome Prepotency Task - Error Rate   [ Time Frame: Week 4 ]

Measure Type Primary
Measure Title Preparing to Overcome Prepotency Task - Error Rate
Measure Description 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
L-830982 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.
Placebo Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.

Measured Values
   L-830982   Placebo 
Participants Analyzed 
[Units: Participants]
 		 9   6 
Preparing to Overcome Prepotency Task - Error Rate 
[Units: Proportion of errors]
Mean (Standard Deviation) 		 0.042  (0.042)   0.031  (0.074) 


Statistical Analysis 1 for Preparing to Overcome Prepotency Task - Error Rate
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] 0.249
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



6.  Secondary:   Brief Psychiatric Rating Scale Total Score   [ Time Frame: Week 4 ]

Measure Type Secondary
Measure Title Brief Psychiatric Rating Scale Total Score
Measure Description 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One subject dropped out prior to completing study

Reporting Groups
  Description
L-830982 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.
Placebo Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.

Measured Values
   L-830982   Placebo 
Participants Analyzed 
[Units: Participants]
 		 9   6 
Brief Psychiatric Rating Scale Total Score 
[Units: Scores on a scale]
Mean (Standard Deviation) 		 26.3  (5.3)   27.0  (3.0) 


Statistical Analysis 1 for Brief Psychiatric Rating Scale Total Score
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] 0.01
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  At week 4, mean BPRS total scores were nearly the same for the placebo group and L-830982 group as a result of a significant reduction in positive symptoms reported for the placebo group (F=9.12, df=1,13, p=0.01). For the L-830982-treated group, neither total BPRS scores nor any of the factor scores changed over the course of the trial.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



7.  Secondary:   Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score   [ Time Frame: Week 4 ]

Measure Type Secondary
Measure Title Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score
Measure Description 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One subject dropped out before completing the study.

Reporting Groups
  Description
L-830982 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.
Placebo Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.

Measured Values
   L-830982   Placebo 
Participants Analyzed 
[Units: Participants]
 		 9   6 
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score 
[Units: Standard Score]
Mean (Standard Deviation) 		 76.7  (13.5)   70.8  (12.4) 


Statistical Analysis 1 for Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] <0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



8.  Secondary:   Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex   [ Time Frame: Week 4 ]

Measure Type Secondary
Measure Title Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex
Measure Description 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
One subject dropped out before completing the study.

Reporting Groups
  Description
L-830982 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.
Placebo Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.

Measured Values
   L-830982   Placebo 
Participants Analyzed 
[Units: Participants]
 		 9   6 
Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex 
[Units: Standard Score]
Mean (Standard Deviation) 		 85.3  (15.7)   63.8  (17.6) 


Statistical Analysis 1 for Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] <0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size; RBANS may lack appropriate sensitivity for short-term study; between-group differences in baseline clinical symptoms & neuropsychological function; excluding those with more modest cognitive impairments (RBANS standard score >90).


  More Information