MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00506077

First received: July 24, 2007

Last updated: February 10, 2011

Last verified: February 2011

History of Changes

Results First Received: October 13, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Paranoid Schizophrenia
Interventions:	Drug: MK0249 Drug: Comparator: Placebo (unspecified)

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
First Patient Dosed: 11 February 2008; Last Patient Last Treatment: 08 October 2008. Six ex-U.S. study centers (3 Russia, 3 India).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At visit 1, patients were assessed using the protocol eligibility criteria. Eligible patients continued into an 8 day single-blind placebo washout/run-in period, and then were randomized at visit 3 to 1 of 2 cross-over treatment sequences.

Reporting Groups

	Description
MK0249 Then Placebo	These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
Placebo Then MK0249	These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.

Participant Flow for 3 periods

Period 1: Treatment Period 1

	MK0249 Then Placebo	Placebo Then MK0249
STARTED	28	27
COMPLETED	24	24
NOT COMPLETED	4	3
Adverse Event	2	1
Lost to Follow-up	0	2
Withdrawal by Subject	2	0

Period 2: Washout

	MK0249 Then Placebo	Placebo Then MK0249
STARTED	24	24
COMPLETED	24	24
NOT COMPLETED	0	0

Period 3: Treatment Period 2

	MK0249 Then Placebo	Placebo Then MK0249
STARTED	24	24
COMPLETED	23	23
NOT COMPLETED	1	1
Adverse Event	0	1
Withdrawal by Subject	1	0

Baseline Characteristics

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Reporting Groups

	Description
MK0249 Then Placebo	These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
Placebo Then MK0249	These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.
Total	Total of all reporting groups

Baseline Measures

	MK0249 Then Placebo	Placebo Then MK0249	Total
Number of Participants [units: participants]	28	27	55
Age [units: years] Mean ± Standard Deviation	30.7 ± 7.5	32.5 ± 8.4	31.6 ± 7.9
Gender [units: participants]
Female	8	7	15
Male	20	20	40

Outcome Measures

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1. Primary:

Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. [ Time Frame: Baseline and 4 weeks of treatment ]

Measure Type	Primary
Measure Title	Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.
Measure Description	The mean change from baseline after 4 weeks of treatment in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.
Time Frame	Baseline and 4 weeks of treatment
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.
Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.

Reporting Groups

	Description
MK0249	10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
Placebo	10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.

Measured Values

	MK0249	Placebo
Number of Participants Analyzed [units: participants]	47	46
Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. [units: Composite T-score] Least Squares Mean ( 95% Confidence Interval )	0.4 ( -1.2 to 2.1 )	0.5 ( -1.1 to 2.2 )

Statistical Analysis 1 for Mean Change From Baseline at 4 Weeks of Treatment in Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.

Groups ^[1]	All groups
Method ^[2]	constrained longitudinal data analysis
P Value ^[3]	0.939

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The Benjamini & Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.

2. Secondary:

Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score [ Time Frame: Baseline and 4 weeks of treatment ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score
Measure Description	The Attention/Processing Speed Composite Score was comprised of the University of Pennsylvania's Computerized Neuropsychological Battery (CNP) Penn Continuous Performance Test (PCPT) and BACS battery Symbol Coding. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -91 and 91, respectively. Higher values (positive changes from baseline) indicate better performance.
Time Frame	Baseline and 4 weeks of treatment
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.
Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.

Reporting Groups

	Description
MK0249	10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
Placebo	10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.

Measured Values

	MK0249	Placebo
Number of Participants Analyzed [units: participants]	45	45
Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score [units: Composite T-score] Least Squares Mean ( 95% Confidence Interval )	0.5 ( -0.4 to 1.5 )	0.0 ( -0.9 to 0.9 )

Statistical Analysis 1 for Mean Change From Baseline at 4 Weeks of Treatment in Attention/Processing Speed Composite Score

Groups ^[1]	All groups
Method ^[2]	constrained Longitudinal Data Analysis
P Value ^[3]	0.736

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-Value Comments (limit 250 characters): The Benjamini & Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.

3. Secondary:

Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score [ Time Frame: Baseline and 4 weeks of treatment ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score
Measure Description	The Episodic Memory Composite Score was comprised of the University of Pennsylvania’s Computerized Neuropsychological Battery (CNP) Face Memory and BACS battery Verbal Memory. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -202 and 202, respectively. Higher values (positive changes from baseline) indicate better performance.
Time Frame	Baseline and 4 weeks of treatment
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.
Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.

Reporting Groups

	Description
MK0249	10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
Placebo	10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.

Measured Values

	MK0249	Placebo
Number of Participants Analyzed [units: participants]	47	45
Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score [units: Composite T-score] Least Squares Mean ( 95% Confidence Interval )	0.9 ( -0.9 to 2.6 )	0.1 ( -1.6 to 1.8 )

Statistical Analysis 1 for Mean Change From Baseline at 4 Weeks of Treatment in Episodic Memory Composite Score

Groups ^[1]	All groups
Method ^[2]	constrained Longitudinal Data Analysis
P Value ^[3]	0.736

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The Benjamini & Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.

4. Secondary:

Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score [ Time Frame: Baseline and 4 weeks of treatment ]

Measure Type	Secondary
Measure Title	Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score
Measure Description	The Working Memory Composite Score was comprised of the University of Pennsylvania’s Computerized Neuropsychological (CNP) battery N-back test and the BACS battery Digit Sequencing test. The composite score was calculated as a weighted average of the T-scores (normalized for age) for each test. The minimum and maximum values possible for this composite T-score of the change from baseline were -122 and 122, respectively. Higher values (positive changes from baseline) indicate better performance.
Time Frame	Baseline and 4 weeks of treatment
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.
Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.

Reporting Groups

	Description
MK0249	10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
Placebo	10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.

Measured Values

	MK0249	Placebo
Number of Participants Analyzed [units: participants]	44	43
Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score [units: Composite T-score] Least Squares Mean ( 95% Confidence Interval )	0.8 ( -1.0 to 2.6 )	-0.2 ( -2.0 to 1.5 )

Statistical Analysis 1 for Mean Change From Baseline at 4 Weeks of Treatment in Working Memory Composite Score

Groups ^[1]	All groups
Method ^[2]	constrained Logitudinal Data Analysis
P Value ^[3]	0.736

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The Benjamini & Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.

5. Other Pre-specified:

Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. [ Time Frame: Pre-randomization Baseline ]

Measure Type	Other Pre-specified
Measure Title	Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.
Measure Description	Pre-randomization baseline values for all treatment sequences are equal because the constrained longitudinal data analysis (cLDA) model was used (Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148).
Time Frame	Pre-randomization Baseline
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.
Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.

Reporting Groups

	Description
MK0249	10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
Placebo	10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.

Measured Values

	MK0249	Placebo
Number of Participants Analyzed [units: participants]	47	46
Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery. [units: Composite T-score] Least Squares Mean ± Standard Error	40.5 ± 0.98	40.5 ± 0.98

No statistical analysis provided for Pre-randomization Baseline: Total Cognitive Score on the Brief Assessment of Cognition in Schizophrenia (BACS) Battery.

6. Other Pre-specified:

Pre-randomization Baseline: Attention/Processing Speed Composite Score [ Time Frame: Pre-randomization Baseline ]

Measure Type	Other Pre-specified
Measure Title	Pre-randomization Baseline: Attention/Processing Speed Composite Score
Measure Description	Pre-randomization baseline values for all treatment sequences are equal because the constrained longitudinal data analysis (cLDA) model was used (Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148).
Time Frame	Pre-randomization Baseline
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.
Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.

Reporting Groups

	Description
MK0249	10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
Placebo	10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.

Measured Values

	MK0249	Placebo
Number of Participants Analyzed [units: participants]	45	45
Pre-randomization Baseline: Attention/Processing Speed Composite Score [units: Composite T-score] Least Squares Mean ± Standard Error	47.8 ± 0.73	47.8 ± 0.73

No statistical analysis provided for Pre-randomization Baseline: Attention/Processing Speed Composite Score

7. Other Pre-specified:

Pre-randomization Baseline: Episodic Memory Composite Score [ Time Frame: Pre-randomization Baseline ]

Measure Type	Other Pre-specified
Measure Title	Pre-randomization Baseline: Episodic Memory Composite Score
Measure Description	Pre-randomization baseline values for all treatment sequences are equal because the constrained longitudinal data analysis (cLDA) model was used (Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148).
Time Frame	Pre-randomization Baseline
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.
Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.

Reporting Groups

	Description
MK0249	10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
Placebo	10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.

Measured Values

	MK0249	Placebo
Number of Participants Analyzed [units: participants]	47	45
Pre-randomization Baseline: Episodic Memory Composite Score [units: Composite T-score] Least Squares Mean ± Standard Error	43.9 ± 1.16	43.9 ± 1.16

No statistical analysis provided for Pre-randomization Baseline: Episodic Memory Composite Score

8. Other Pre-specified:

Pre-randomization Baseline: Working Memory Composite Score [ Time Frame: Pre-randomization Baseline ]

Measure Type	Other Pre-specified
Measure Title	Pre-randomization Baseline: Working Memory Composite Score
Measure Description	Pre-randomization baseline values for all treatment sequences are equal because the constrained longitudinal data analysis (cLDA) model was used (Liang and Zeger, 2000, Sankhya: The Indian Journal of Statistics, Series B 62, 134–148).
Time Frame	Pre-randomization Baseline
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.
Full Analysis Set (FAS): The FAS included all randomized patients who took at lease one dose of study medication and had at least one post-randomization efficacy measurement in either of the two treatment periods. The data as observed (DAO) approach was used to handle missing data.

Reporting Groups

	Description
MK0249	10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
Placebo	10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.

Measured Values

	MK0249	Placebo
Number of Participants Analyzed [units: participants]	44	43
Pre-randomization Baseline: Working Memory Composite Score [units: Composite T-score] Least Squares Mean ± Standard Error	43.5 ± 0.98	43.5 ± 0.98

No statistical analysis provided for Pre-randomization Baseline: Working Memory Composite Score

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
No text entered.

Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided by Merck

Publications automatically indexed to this study:

F Egan M, Zhao X, Gottwald R, Harper-Mozley L, Zhang Y, Snavely D, Lines C, Michelson D. Randomized crossover study of the histamine H3 inverse agonist MK-0249 for the treatment of cognitive impairment in patients with schizophrenia. Schizophr Res. 2013 May;146(1-3):224-30. doi: 10.1016/j.schres.2013.02.030. Epub 2013 Mar 22.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00506077 History of Changes
Other Study ID Numbers:	MK-0249-016, 2007_522
Study First Received:	July 24, 2007
Results First Received:	October 13, 2010
Last Updated:	February 10, 2011
Health Authority:	Russia: Pharmacological Committee, Ministry of Health

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