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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_603 |
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This study is to evaluate the safety and efficacy of the study drug compared to placebo in the treatment of cognitive impairment in men with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MK5757 |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK5757 | Drug | This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 25 mg capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 MK5757 50 mg capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment | The Brief Assessment of Cognition in Schizophrenia (BACS) was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The BACS composite score was calculated by averaging scores from the BACS subtests, including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Verbal Fluency (Semantic Fluency and Letter Fluency) and Tower of London. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -111.5 and 111.5, respectively. | Baseline and Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score | CogState Schizophrenia Battery was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The composite score was comprised of 4 modules from the CogState Schizophrenia Battery: Identification Task, Detection Task, One Card Learning Task and Groton Maze Learning Task. Composite score was calculated by averaging all available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at 2 weeks of treatment for the endpoint are -347.5 and 347.5, respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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Patients in this cross-over study were randomly assigned to placebo or MK5757 for 2 weeks separated by a 2-week wash-out period. Women were not permitted to enroll into this study because safety, pharmacokinetic or pharmacodynamic properties of MK5757 in women have not been established.
First Patient Evaluated: 14-Oct-2008, Last Patient Last Visit: 18-Jun-2009; 6 sites (2 United States, 4 Russia). In total, enrollment lasted approximately 8 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK5757 / Placebo | Patients were randomly assigned to two weeks of treatment with MK5757 during Treatment Period 1 followed by a 2-week washout followed by administration of placebo during Treatment Period 2. Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period. Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period |
| FG001 | Placebo / MK5757 | Patients were randomly assigned to two weeks of treatment with placebo during Treatment Period 1 followed by a 2-week washout followed by administration of MK5757 during Treatment Period 2. Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period. Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Treatment Period 1) |
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| ||||||||||||||||||||||||
| Washout Period of Two Weeks |
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| Second Intervention (Treatment Period 2) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK5757 / Placebo | Patients were randomly assigned to two weeks of treatment with MK5757 during Treatment Period 1 followed by a 2-week washout followed by administration of placebo during Treatment Period 2. Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period. Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in the Composite Score From the Brief Assessment of Cognition in Schizophrenia (BACS) Battery After 2 Weeks of Treatment | The Brief Assessment of Cognition in Schizophrenia (BACS) was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The BACS composite score was calculated by averaging scores from the BACS subtests, including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Verbal Fluency (Semantic Fluency and Letter Fluency) and Tower of London. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -111.5 and 111.5, respectively. | Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | T-score based on normative data | Baseline and Week 2 |
|
All clinical adverse events within 14 days post dose and all laboratory adverse events post dose are included.
The number of patients listed in the Adverse Event tables is the number of
patients who received study treatment and had follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK5757 | MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Electrocardiogram QT prolonged | Investigations | MedDRA 12.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus bradycardia | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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|
| Comparator: Placebo | Drug | This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 one placebo capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 two MK5757 placebo capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days. |
|
| Baseline and week 2 |
| Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score | The Executive Functioning Composite Score was comprised of the following tests: Groton Maze Learning Task from the CogState Schizophrenia Battery and Tower of London, Semantic Fluency and Letter Fluency tests from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -253.4 and 253.4, respectively. | Baseline and Week 2 |
| Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score | The Episodic Memory Composite Score was comprised of the following tests: Continuous Paired Associate Learning Task and One Card Learning Task from the CogState Schizophrenia Battery and the Verbal Memory test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -207.06 and 207.06, respectively. | Baseline and Week 2 |
| Mean Change From Baseline After 2 Weeks of Treatment in the Working Memory Composite Score | The Working Memory Composite Score was comprised of the following tests: Two-Back Memory Task from the CogState Schizophrenia Battery and the Digit Sequencing test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -27.06 and 27.06, respectively. | Baseline and Week 2 |
| Mean Change From Baseline After 2 Weeks of Treatment in the Attention/Processing Speed Composite Score | The Attention/Processing Speed Composite Score was comprised of the following tests: Identification Task and the Detection Task from the CogState Schizophrenia Battery and the Symbol Coding test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -287.15 and 287.15, respectively. | Baseline and Week 2 |
| Withdrawal by Subject |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
|
| BG001 | Placebo / MK5757 | Patients were randomly assigned to two weeks of treatment with placebo during Treatment Period 1 followed by a 2-week washout followed by administration of MK5757 during Treatment Period 2. Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period. Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Study Region | Number | participants |
|
| OG000 |
| MK5757 |
MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period. |
| OG001 | Placebo | Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period. |
|
|
|
| Secondary | Mean Change From Baseline After 2 Weeks of Treatment in the CogState Composite Score | CogState Schizophrenia Battery was used to evaluate cognitive impairment, as measured by the mean change from baseline after 2 weeks of treatment in the composite score. The composite score was comprised of 4 modules from the CogState Schizophrenia Battery: Identification Task, Detection Task, One Card Learning Task and Groton Maze Learning Task. Composite score was calculated by averaging all available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at 2 weeks of treatment for the endpoint are -347.5 and 347.5, respectively. | Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | T-score based on normative data | Baseline and week 2 |
|
|
|
|
| Secondary | Mean Change From Baseline After 2 Weeks of Treatment in the Executive Functioning Composite Score | The Executive Functioning Composite Score was comprised of the following tests: Groton Maze Learning Task from the CogState Schizophrenia Battery and Tower of London, Semantic Fluency and Letter Fluency tests from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -253.4 and 253.4, respectively. | Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | T-score based on normative data | Baseline and Week 2 |
|
|
|
|
| Secondary | Mean Change From Baseline After 2 Weeks of Treatment in the Episodic Memory Composite Score | The Episodic Memory Composite Score was comprised of the following tests: Continuous Paired Associate Learning Task and One Card Learning Task from the CogState Schizophrenia Battery and the Verbal Memory test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -207.06 and 207.06, respectively. | Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | T-score based on normative data | Baseline and Week 2 |
|
|
|
|
| Secondary | Mean Change From Baseline After 2 Weeks of Treatment in the Working Memory Composite Score | The Working Memory Composite Score was comprised of the following tests: Two-Back Memory Task from the CogState Schizophrenia Battery and the Digit Sequencing test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -27.06 and 27.06, respectively. | Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | T-score based on normative data | Baseline and Week 2 |
|
|
|
|
| Secondary | Mean Change From Baseline After 2 Weeks of Treatment in the Attention/Processing Speed Composite Score | The Attention/Processing Speed Composite Score was comprised of the following tests: Identification Task and the Detection Task from the CogState Schizophrenia Battery and the Symbol Coding test from the BACS. The composite score was calculated by averaging all of the available standardized tests scores for the specified tests. The possible minimum and maximum scores for change from baseline at two weeks of treatment for the endpoint are -287.15 and 287.15, respectively. | Full Analysis Set (FAS): The FAS population was a subset of all randomized patients which included randomized patients who received at least one dose of study treatment and had at least one measurement in any of the two treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | T-score based on normative data | Baseline and Week 2 |
|
|
|
|
| 0 |
| 48 |
| 15 |
| 48 |
| EG001 | Placebo | Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period. | 1 | 52 | 8 | 52 |
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Electrocardiogram change | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
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.