Phase 2
Completed N=60
Efficacy and Safety of Armodafinil as Adjunctive Therapy in Schizophrenic Adults With Cognitive Deficits
Source: ClinicalTrials.gov NCT00487942 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Dec 2010
Primary outcomePrimary: Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery — 1.9; 2.8; 2.9; 2.2 Units on a scale
Summary
The primary objective of this study is to evaluate if adjunctive armodafinil treatment can improve the cognitive deficits in patients with schizophrenia
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to Last Observation After Baseline in Composite Score on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery |
1.9; 2.8; 2.9; 2.2 | — |
| SECONDARY Change From Baseline to Week 4 in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery Composite Score |
2.2; 3.9; 2.9; 2.1 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Speed of Processing Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery |
3.0; 0.0; 5.0; 0.9 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Attention/Vigilance Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery |
0.4; 3.7; 1.8; 3.0 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Working Memory Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery |
2.3; 4.3; 3.5; 4.4 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Verbal Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery |
-1.2; -0.8; 0.8; -2.2 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Visual Learning Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery |
4.3; 3.9; 1.3; 0.2 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Reasoning and Problem Solving Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery |
1.6; -0.4; -0.3; -0.2 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Social Cognition Domain of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery |
-3.1; -1.3; 3.6; 3.8 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Trail Making Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery |
4.2; -0.2; 9.2; -1.0 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Brief Assessment of Cognition in Schizophrenia: Symbol Coding (BASC SC) Test of the MATRICS Consensus Cognitive Battery |
0.6; -0.4; 2.4; 4.0 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Fluency Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery |
2.2; 0.8; -0.5; -1.4 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Wechsler Memory Scale: Spatial Span (WMS-III SS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery |
0.7; 4.7; 2.9; 2.5 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Letter-Number Span (LNS) Test of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery |
3.1; 2.1; 3.1; 4.5 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Number of Perseverative Errors |
1.6; -8.0; -2.2; -1.9 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Consecutive Responses on the Final Category |
-1.6; -0.5; 0.3; 0.7 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Wisconsin Card Sort Test (WCST) - Categories Completed |
0.0; 0.5; -0.3; 0.2 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Trails B Test |
-8.7; 17.5; -20.8; -27.6 | — |
| SECONDARY Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Average Activity |
-17.6; -0.7; 4.2; 0.8 | — |
| SECONDARY Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Average Activity |
-2.3; 8.9; 2.1; 0.8 | — |
| SECONDARY Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Average Activity |
-15.4; -7.9; -7.2; 13.1 | — |
| SECONDARY Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Average Activity |
1.5; 7.2; 9.9; -1.6 | — |
| SECONDARY Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Average Activity |
-15.4; 9.0; -0.4; -18.7 | — |
| SECONDARY Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Maximum Activity |
-124.3; -73.2; 70.4; -5.9 | — |
| SECONDARY Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Maximum Activity |
-85.7; 14.8; 20.5; 6.2 | — |
| SECONDARY Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Maximum Activity |
-152.7; -146.3; 11.8; -28.4 | — |
| SECONDARY Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Maximum Activity |
1420.4; 1522.5; 1469.2; 1505.1 | — |
| SECONDARY Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Maximum Activity |
-173.5; -61.4; 57.5; -60.4 | — |
| SECONDARY Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Standard Deviation of Activity |
-5.1; -0.7; 6.0; -1.9 | — |
| SECONDARY Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Standard Deviation of Activity |
-4.3; 7.6; 4.2; 1.7 | — |
| SECONDARY Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Standard Deviation of Activity |
-11.3; -6.6; -6.6; -0.3 | — |
| SECONDARY Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Standard Deviation of Activity |
5.2; -6.6; 15.2; 1.1 | — |
| SECONDARY Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Standard Deviation of Activity |
-7.9; 6.3; 7.4; -7.6 | — |
| SECONDARY Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Median Value for Actigraphy Data of Total Activity |
7037.0; -9164.8; 23631.1; -24811.4 | — |
| SECONDARY Change From Baseline to Week 1 in the Median Value for Actigraphy Data of Total Activity |
5913.6; -3818.5; 23665.1; -12675.4 | — |
| SECONDARY Change From Baseline to Week 2 in the Median Value for Actigraphy Data of Total Activity |
2346.8; -32082.8; 3103.1; 30660.0 | — |
| SECONDARY Change From Baseline to Week 3 in the Median Value for Actigraphy Data of Total Activity |
39831.8; 16850.4; 56889.1; 29067.5 | — |
| SECONDARY Change From Baseline to Week 4 in the Median Value for Actigraphy Data of Total Activity |
1341.8; 12620.9; 55151.0; -24323.9 | — |
| SECONDARY Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Minimum Value for Actigraphy Data of Total Activity |
-41210.0; -16150.5; -5159.5; -34443.8 | — |
| SECONDARY Change From Baseline to Week 1 in the Minimum Value for Actigraphy Data of Total Activity |
2419.5; 37665.8; 15892.7; 1116.3 | — |
| SECONDARY Change From Baseline to Week 2 in the Minimum Value for Actigraphy Data of Total Activity |
-3534.2; 27543.3; 7937.0; 27759.5 | — |
| SECONDARY Change From Baseline to Week 3 in the Minimum Value for Actigraphy Data of Total Activity |
89886.7; 91057.2; 126496.5; 60259.0 | — |
| SECONDARY Change From Baseline to Week 4 in the Minimum Value for Actigraphy Data of Total Activity |
-12493.6; -6742.8; 39458.0; 1744.3 | — |
| SECONDARY Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Maximum Value for Actigraphy Data of Total Activity |
175906.8; 45621.4; 144855.3; 38708.1 | — |
| SECONDARY Change From Baseline to Week 1 in the Maximum Value for Actigraphy Data of Total Activity |
92077.4; -28961.9; 18639.8; -118038 | — |
| SECONDARY Change From Baseline to Week 2 in the Maximum Value for Actigraphy Data of Total Activity |
-46326.7; -44034.8; -1954.7; -78154.5 | — |
| SECONDARY Change From Baseline to Week 3 in the Maximum Value for Actigraphy Data of Total Activity |
40120.5; 23748.0; 61304.7; -41751.7 | — |
| SECONDARY Change From Baseline to Week 4 in the Maximum Value for Actigraphy Data of Total Activity |
7898.0; -10300.1; 123442.9; -240840 | — |
| SECONDARY Change From Baseline to Endpoint (Week 4 or Last Observation After Baseline) in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores |
-3.9; -0.7; -4.6; -3.1 | — |
| SECONDARY Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores |
-5.0; -3.0; -1.6; -3.3 | — |
| SECONDARY Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Scores |
-3.8; -1.8; -4.6; -2.6 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating |
0.3; -0.2; -0.3; -0.4 | — |
| SECONDARY Change From Baseline to Week 2 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating |
0.0; -0.3; 0.6; -0.8 | — |
| SECONDARY Change From Baseline to Week 4 in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Global Rating |
-0.1; -0.4; -0.3; -0.5 | — |
| SECONDARY Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 or Last Observation Following Baseline |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Patient Global Impression of Change (PGIC) at Week 4 or Last Observation Following Baseline |
1; 2; 4; 3; 3; 2 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in Scale for the Assessment of Negative Symptoms (SANS) Total Scores |
-5.6; -3.0; -7.4; -6.1 | — |
| SECONDARY Change From Baseline to Week 1 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores |
-1.4; -2.5; -2.2; -2.2 | — |
| SECONDARY Change From Baseline to Week 2 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores |
0.4; -4.5; -4.4; -6.8 | — |
| SECONDARY Change From Baseline to Week 4 in Scale for the Assessment of Negative Symptoms (SANS) Total Scores |
-5.3; -5.6; -7.4; -6.3 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation After Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score |
-0.3; -0.3; -3.4; 0.1 | — |
| SECONDARY Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score |
0.4; -0.1; -2.5; -0.4 | — |
| SECONDARY Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score |
-0.1; -1.4; -2.3; -0.8 | — |
| SECONDARY Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Negative Scale Score |
-0.1; -1.3; -3.4; 0.0 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation Following Baseline in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score |
-2.5; -0.9; -6.3; -1.7 | — |
| SECONDARY Change From Baseline to Week 1 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score |
0.5; -0.8; -4.0; -2.3 | — |
| SECONDARY Change From Baseline to Week 2 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score |
-2.1; -3.2; -3.0; -2.8 | — |
| SECONDARY Change From Baseline to Week 4 in the Positive and Negative Symptom Scale for Schizophrenia (PANSS) Total Score |
-2.1; -3.1; -6.3; -2.1 | — |
| SECONDARY Change From Baseline to Week 4 or Last Observation Following Baseline in Epworth Sleepiness Scale (ESS) Total Scores |
-2.1; -0.6; 1.0; -0.5 | — |
| SECONDARY Change From Baseline to Week 1 in Epworth Sleepiness Scale (ESS) Total Scores |
-2.2; -1.4; 0.0; -1.5 | — |
| SECONDARY Change From Baseline to Week 2 in Epworth Sleepiness Scale (ESS) Total Scores |
-1.1; -1.6; 0.3; -2.1 | — |
| SECONDARY Change From Baseline to Week 4 in Epworth Sleepiness Scale (ESS) Total Scores |
-2.0; -0.5; 1.0; -1.7 | — |
| SECONDARY Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 1 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 2 |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Week 4 |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Patient Global Impression of Change (PGIC) at Week 1 |
1; 2; 2; 1; 1; 1 | — |
| SECONDARY Patient Global Impression of Change (PGIC) at Week 2 |
1; 2; 2; 3; 3; 1 | — |
| SECONDARY Patient Global Impression of Change (PGIC) at Week 4 |
1; 2; 4; 3; 3; 2 | — |
| SECONDARY Clinical Global Impression of Severity of Illness (CGI-S) Ratings at Baseline |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- The patient has a diagnosis of schizophrenia according to the DSM-IV-TR criteria as determined by the SCID and has been clinically stable in a nonacute phase of their illness for at least 8 weeks prior to the baseline visit.
- The patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of olanzapine, oral risperidone, or paliperidone for at least 4 weeks prior to the screening visit. The patient is prepared to remain at these stable dosages for the duration of the study.
- The patient is a man or woman 18 through 60 years of age.
- The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator on the basis of medical and psychiatric history, medical examination, ECG, serum chemistry, hematology, and urinalysis.
- Women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
- The patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation as specified in this protocol.
Key Exclusion Criteria
- The patient has any Axis I disorder, including schizoaffective disorder and sleep disorders, apart from schizophrenia, and nicotine dependence.
- The patient has tardive dyskinesia or any other clinically significant movement disorder.
- The patient has any clinically significant uncontrolled medical (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition.
- The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
- The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
Data sourced from ClinicalTrials.gov (NCT00487942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.