Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Armodafinil (200 mg/Day)	Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
Placebo	Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.

Participant Flow:   Overall Study

	Armodafinil (200 mg/Day)	Placebo
STARTED	21	19
COMPLETED	20	16
NOT COMPLETED	1	3
Adverse Event	1	1
Withdrawal by Subject	0	1
Protocol Violation	0	1

Reporting Groups

	Description
Armodafinil (200 mg/Day)	Armodafinil was titrated during the double-blind treatment period starting with 50 mg/day (1 tablet) on Day 1, increasing to 100 mg/day (2 tablets) on day 2, 150 mg/day (3 tablets) on day 5, and 200 mg/day (4 tablets) on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
Placebo	Placebo tablets matching the armodafinil tablets were titrated during the double-blind treatment period starting with 1 tablet/day on Day 1, increasing to 2 tablets/day on day 2, 3 tablets/day on day 5, and 4 tablets/day on day 8, which was continued for the remainder of the 2-week double-blind treatment period.
Total	Total of all reporting groups

Baseline Measures

	Armodafinil (200 mg/Day)	Placebo	Total
Number of Participants   [units: participants]	21	19	40
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	21	19	40
>=65 years	0	0	0
Age   [units: years] Mean ± Standard Deviation	49.9  ± 8.98	50.7  ± 7.95	50.3  ± 8.41
Gender   [units: participants]
Female	4	5	9
Male	17	14	31
Region of Enrollment   [units: participants]
United States	21	19	40

1.  Primary:

Change From Baseline to Endpoint in Number of Contiguous Activated Voxels Meeting Predefined Threshold in Dorsolateral Prefrontal Cortex (DLPFC) on Functional Magnetic Resonance Imaging (fMRI) as a Measure of Prefrontal Cortical Activation   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

2.  Secondary:

Change From Baseline to Endpoint in Mean Response Latency in the 2-Back Working Memory Test at Endpoint - Mean Performance Speed   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

3.  Secondary:

Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Anterior Cingulate Cortex (ACC)   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

4.  Secondary:

Change From Baseline to Endpoint in the Number of Contiguous Voxels Meeting the Predefined Threshold in the Posterior Parietal Cortex (PPC)   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

5.  Secondary:

Change From Baseline to Endpoint in the Number of Contiguous Activated Voxels Meeting the Predefined Threshold in the Thalamus   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

6.  Secondary:

Pattern Recognition Memory (PRM) Percent Correct (Immediate) From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

7.  Secondary:

Pattern Recognition Memory (PRM) Percent Correct (Delayed) From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

8.  Secondary:

Reaction Time Index (RTI) Median Correct Latency, Five Choice Test From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

9.  Secondary:

Reaction Time Index (RTI) Median Correct Latency, One Choice Test From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

10.  Secondary:

One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

11.  Secondary:

One Touch Stockings of Cambridge (OTS) Mean Correct Latency, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

12.  Secondary:

One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Easy) From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

13.  Secondary:

One Touch Stockings of Cambridge (OTS) Mean Choices to Correct, (Hard) From the CANTAB Battery-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

14.  Secondary:

Epworth Sleepiness Scale Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

15.  Secondary:

Clinical Global Impression of Change (CGI-C)- Number of Responders at Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

16.  Secondary:

Total Score From the Medical Outcomes Study 6-Item Cognitive Function Scale (MOS-CF6)-Change From Baseline to Endpoint   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

17.  Secondary:

Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Dorsolateral Prefrontal Cortex (DLPFC)   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

18.  Secondary:

Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Anterior Cingulate Cortex (ACC)   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

19.  Secondary:

Blood Oxygenation Level Dependent (BOLD) Signal Intensity -Change From Baseline to Endpoint in the Posterior Parietal Cortex (PPC)   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

20.  Secondary:

Blood Oxygenation Level Dependent (BOLD) Signal Intensity - Percent Change From Baseline to Endpoint in the Thalamus   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

21.  Secondary:

Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint   [ Time Frame: Endpoint (Week 2 or last observation after baseline) ]

22.  Secondary:

Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test - Number of Voxels Activated at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

23.  Secondary:

Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and the 2-Back Working Memory Test -Number of Voxels Activated at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

24.  Secondary:

Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test -Number of Voxels Activated at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

25.  Secondary:

Activation-Performance Relationship Between the Functional Magnetic Resonance Imaging (fMRI) in Dorsolateral Prefrontal Cortex (DLPFC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

26.  Secondary:

Activation-Performance Relationship Between Functional Magnetic Resonance Imaging (fMRI) in Anterior Cingulate Cortex (ACC) and 2-Back Working Memory Test -Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

27.  Secondary:

Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in Posterior Parietal Cortex (PPC) and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

28.  Secondary:

Activation-Performance Relationship on Functional Magnetic Resonance Imaging (fMRI) in the Thalamus and 2-Back Working Memory Test - Blood Oxygen Level Dependent (BOLD) Signal Intensity at Endpoint   [ Time Frame: Week 2 or Last Observation after Baseline ]

29.  Secondary:

Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI on the 2 Back Working Memory Test - Change From Baseline-Subgroup-Responders in 2 Back Working Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

30.  Secondary:

Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test -Change From Baseline; Subgroup-Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

31.  Secondary:

Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

32.  Secondary:

Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

33.  Secondary:

Number of Contiguous Activated Voxels Meeting Predefined Threshold in the DLPFC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

34.  Secondary:

Number of Contiguous Activated Voxels Meeting Predefined Threshold in the ACC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

35.  Secondary:

Number of Contiguous Activated Voxels Meeting Predefined Threshold in the PPC on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

36.  Secondary:

Number of Contiguous Activated Voxels Meeting Predefined Threshold in the Thalamus on fMRI by 2-Back Working Memory Test-Change From Baseline; Subgroup-Non Responders in 2 Back Memory Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

37.  Secondary:

Change From Baseline to Endpoint in the BOLD Signal Intensity in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

38.  Secondary:

Change From Baseline to Endpoint in the BOLD Signal Intensity in the Anterior Cingulate Cortex (ACC) at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after Baseline) ]

39.  Secondary:

Change From Baseline in the BOLD Signal Intensity in the Posterior Parietal Cortex (PPC) at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

40.  Secondary:

Change From Baseline to Endpoint in the BOLD Signal Intensity in the Thalamus at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after Baseline) ]

41.  Secondary:

Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Dorsolateral Prefrontal Cortex (DLPFC) at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

42.  Secondary:

Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Anterior Cingulate Cortex (ACC) at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after Baseline) ]

43.  Secondary:

Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in Posterior Parietal Cortex (PPC) at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after Baseline) ]

44.  Secondary:

Change From Baseline to Endpoint in the Number of Voxels Meeting Predefined Threshold in the Thalamus at Resting State   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after baseline) ]

45.  Secondary:

Change From Baseline to Endpoint (2 Weeks or Last Observation After Baseline) in the Mean Response Latency in the Psychomotor Vigilance-Like Test   [ Time Frame: Baseline and Endpoint (Week 2 or last observation after Baseline) ]