TY - JOUR
T1 - The effect of adjunctive armodafinil on cognitive performance and psychopathology in antipsychotic-treated patients with schizophrenia/schizoaffective disorder
T2 - A randomized, double-blind, placebo-controlled trial
AU - Bobo, William V.
AU - Woodward, Neil D.
AU - Sim, Min Young
AU - Jayathilake, Karuna
AU - Meltzer, Herbert Y.
N1 - Funding Information:
Funding for this study was provided by a NARSAD Young Investigator grant (William V. Bobo) and an investigator-initiated research grant from Cephalon, Inc. (Herbert Y. Meltzer). Neither funding source had any further role in study design; in the collection, analysis or interpretation of data; in writing the report; or in the decision to submit the paper for publication.
PY - 2011/8
Y1 - 2011/8
N2 - Background: The efficacy, safety and tolerability of adjunctive armodafinil for cognitive performance, and negative and affective symptoms, were examined in 60 patients with schizophrenia or schizoaffective disorder. Method: This was a 6-week, double-blind, placebo-controlled, fixed dose trial of armodafinil (150. mg/d) augmentation in patients with clinically stable schizophrenia or schizoaffective disorder. Cognition, psychopathology, alertness/wakefulness and adverse effects were assessed with standardized rating instruments. The primary endpoint was performance on measures of attention/vigilance. Results: Patients were randomly allocated to adjunctive armodafinil or placebo. There was a significant Drug × Time interaction effect for attention/vigilance, due to modest non-significant worsening in the armodafinil group and improvement in the armodafinil group [CPT-Pairs d', F(1,40) = 6.2, p = 0.017]. However, it became non-significant after correction for multiple comparisons. There were no differences between armodafinil and placebo in other cognitive domains or psychopathology measures. However, armodafinil was associated with significant improvement in the Scale for the Assessment of Negative Symptoms (SANS) anhedonia-asociality [F(1,41) = 4.1, p = 0.05]. Conclusions: There were no significant differences in neurocognitive measures between adjunctive armodafinil and placebo in this 6-week study. Armodafinil improved anhedonia-asociality, but not other negative symptom domains.
AB - Background: The efficacy, safety and tolerability of adjunctive armodafinil for cognitive performance, and negative and affective symptoms, were examined in 60 patients with schizophrenia or schizoaffective disorder. Method: This was a 6-week, double-blind, placebo-controlled, fixed dose trial of armodafinil (150. mg/d) augmentation in patients with clinically stable schizophrenia or schizoaffective disorder. Cognition, psychopathology, alertness/wakefulness and adverse effects were assessed with standardized rating instruments. The primary endpoint was performance on measures of attention/vigilance. Results: Patients were randomly allocated to adjunctive armodafinil or placebo. There was a significant Drug × Time interaction effect for attention/vigilance, due to modest non-significant worsening in the armodafinil group and improvement in the armodafinil group [CPT-Pairs d', F(1,40) = 6.2, p = 0.017]. However, it became non-significant after correction for multiple comparisons. There were no differences between armodafinil and placebo in other cognitive domains or psychopathology measures. However, armodafinil was associated with significant improvement in the Scale for the Assessment of Negative Symptoms (SANS) anhedonia-asociality [F(1,41) = 4.1, p = 0.05]. Conclusions: There were no significant differences in neurocognitive measures between adjunctive armodafinil and placebo in this 6-week study. Armodafinil improved anhedonia-asociality, but not other negative symptom domains.
KW - Adjunctive treatment
KW - Armodafinil
KW - Depressive symptoms
KW - Negative symptoms
KW - Neurocognition
KW - Schizophrenia
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U2 - 10.1016/j.schres.2011.05.015
DO - 10.1016/j.schres.2011.05.015
M3 - Article
C2 - 21641776
AN - SCOPUS:79960315525
SN - 0920-9964
VL - 130
SP - 106
EP - 113
JO - Schizophrenia Research
JF - Schizophrenia Research
IS - 1-3
ER -