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

This study has been completed.

Sponsor:

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00129441

First received: August 10, 2005

Last updated: October 14, 2011

Last verified: October 2011

History of Changes

Results First Received: May 25, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Schizophrenia
Interventions:	Drug: Merck L-830982 Drug: Placebo

Participant Flow

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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

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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
Number of Participants [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)
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)
AX Continuous Performance Test Task d-prime ^[2] [units: d-prime] Mean (Standard Deviation)	0.9 (0.7)	0.7 (0.9)	0.8 (0.7)
Preparing to Overcome Prepotency (POP) Task - Reaction Time ^[3] [units: msec] Mean (Standard Deviation)	66 (48)	36 (61)	54 (53)
Preparing to Overcome Prepotency (POP) Task - Error Rate ^[3] [units: proportion of errors] Mean (Standard Deviation)	0.034 (0.050)	0.064 (0.068)	0.046 (0.058)
Brief Psychiatric Rating Scale (BPRS) Total Score ^[4] [units: Scores on a scale] Mean (Standard Deviation)	24.3 (2.6)	34.2 (7.1)	28.3 (6.9)
Repeatable Battery for the Assessment of Neuropsychological Status: RBANS Total Score ^[5] [units: Standard Score] Mean (Standard Deviation)	71.8 (10.6)	63.5 (7.1)	68.5 (10.0)
Repeatable Battery for the Assessment of Neuropsychological Status: RBANS Delayed Memory Subindex ^[6] [units: Standard Score] Mean (Standard Deviation)	76.8 (15.5)	60.8 (16.1)	70.4 (17.2)

[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.
[2]	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.
[3]	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.
[4]	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).
[5]	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).
[6]	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

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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
Safety Issue	No

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
Number of 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
Method ^[2]	ANOVA
P Value ^[3]	0.16

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[3]	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
Safety Issue	No

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
Number of 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
Method ^[2]	ANOVA
P Value ^[3]	0.162

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[3]	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
Safety Issue	No

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
Number of 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
Method ^[2]	ANOVA
P Value ^[3]	0.12

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[3]	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
Safety Issue	No

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
Number of 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
Method ^[2]	ANOVA
P Value ^[3]	0.05

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[3]	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
Safety Issue	No

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
Number of 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
Method ^[2]	ANOVA
P Value ^[3]	0.249

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[3]	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
Safety Issue	No

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
Number of 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
Method ^[2]	ANOVA
P Value ^[3]	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]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[3]	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
Safety Issue	No

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
Number of 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
Method ^[2]	ANOVA
P Value ^[3]	<0.05

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[3]	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
Safety Issue	No

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
Number of 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
Method ^[2]	ANOVA
P Value ^[3]	<0.05

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[3]	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

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Other Adverse Events

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Limitations and Caveats

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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).

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