Meets criteria for Major Depressive Episode, by Diagnostic Statistical Manual of Mental Disorder - IV (TR) criteria 
Clinically significant agitation /aggression for which either 1) the frequency of agitation /aggression as assessed by the NPI is 'Very frequently', or 2) the frequency of agitation /aggression as assessed by the NPI is 'Frequently' AND the severity of the agitation as assessed by the NPI is 'Moderate', or 'Marked' 
Clinically significant delusions for which either 1) the frequency of delusions as assessed by the NPI is 'Very frequently', or 2) the frequency of delusions as assessed by the NPI is 'Frequently' AND the severity of the delusions as assessed by the NPI is 'Moderate', or 'Marked' 
Clinically significant hallucinations for which either 1) the frequency of hallucinations as assessed by the NPI is 'Very frequently', or 2) the frequency of hallucinations as assessed by the NPI is 'Frequently' AND the severity of the hallucinations as assessed by the NPI is 'Moderate', or 'Marked' 
Treatment with psychotropic medications in the 2 weeks prior to randomization with the exception of approved treatments for dementia (ChEIs and memantine), selective serotonin reuptake inhibitor antidepressants, and trazodone (if used as an aid to facilitate sleep and not as an antidepressant); other psychotropics (with the exclusion of antipsychotics), if stable for 3 months, may be allowed only with Steering Committee approval on a case by case basis. Note that antipsychotics are expressly prohibited. 
Treatment with methylphenidate is contraindicated in the opinion of the study physician 
Failure of treatment with methylphenidate in the past for apathy after convincing evidence of an adequate trial as judged by study physician 
Treatment with a medication that would prohibit the safe concurrent use of methylphenidate such as monoamine oxidase inhibitors and tricyclic antidepressants 
Need for acute psychiatric hospitalization or is suicidal 
Uncontrolled hypertension (medication non-compliance or past 3 months with a diastolic reading of 105 as verified by compartment pressure of the rectus sheath (CPRS)) 
Symptomatic coronary artery disease deemed to be significant by study physician at the time of screening 
Lack of appetite that results in significant unintentional weight loss as determined by the study physician in the last three months 
Significant communicative impairments 
Current participation in a clinical trial or in any study that may add significant burden or affect study outcomes 
Hyperthyroidism, advanced arteriosclerosis, symptomatic cardiovascular disease, serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or a family history of sudden death or death related to heart problems 
Glaucoma, pheochromocytoma, or known or suspected hypersensitivity to methylphenidate or its excipients 
Central Nervous System (CNS) abnormalities (e.g., cerebral aneurysm) and/or other vascular abnormalities such as vasculitis or pre-existing stroke, motor tics or a family history or diagnosis of Tourette's syndrome, seizures (convulsions, epilepsy), or abnormal EEGs 
Any condition that, in the opinion of the study physician, makes it medically inappropriate or risky for the patient to enroll in the trial       
    

NCT01117181_exc_T1
Condition
Major Depressive Episode
NCT01117181_exc_T2
Measurement
Diagnostic Statistical Manual of Mental Disorder - IV (TR) criteria
NCT01117181_exc_T3
Value
Meets
NCT01117181_exc_T4
Condition
agitation /aggression
NCT01117181_exc_T5
Qualifier
Clinically significant
NCT01117181_exc_T8
Multiplier
frequency of agitation /aggression
NCT01117181_exc_T7
Condition
agitation /aggression
NCT01117181_exc_T9
Measurement
NPI
NCT01117181_exc_T10
Value
Very frequently
NCT01117181_exc_T11
Multiplier
frequency of agitation /aggression
NCT01117181_exc_T12
Condition
agitation /aggression
NCT01117181_exc_T13
Measurement
NPI
NCT01117181_exc_T14
Value
Frequently
NCT01117181_exc_T15
Measurement
NPI
NCT01117181_exc_T16
Value
Moderate
NCT01117181_exc_T17
Value
Marked
NCT01117181_exc_T18
Scope
'Moderate', or 'Marked'
NCT01117181_exc_T19
Qualifier
severity of the agitation
NCT01117181_exc_T20
Condition
agitation
NCT01117181_exc_T21
Condition
delusions
NCT01117181_exc_T22
Qualifier
Clinically significant
NCT01117181_exc_T23
Multiplier
frequency of delusions
NCT01117181_exc_T24
Condition
delusions
NCT01117181_exc_T25
Measurement
NPI
NCT01117181_exc_T26
Value
Very frequently
NCT01117181_exc_T27
Multiplier
frequency of delusions
NCT01117181_exc_T28
Condition
delusions
NCT01117181_exc_T29
Measurement
NPI
NCT01117181_exc_T30
Value
Frequently
NCT01117181_exc_T31
Qualifier
severity of the delusions
NCT01117181_exc_T32
Condition
delusions
NCT01117181_exc_T33
Measurement
NPI
NCT01117181_exc_T34
Value
Moderate
NCT01117181_exc_T35
Value
Marked
NCT01117181_exc_T36
Scope
'Moderate', or 'Marked'
NCT01117181_exc_T37
Condition
hallucinations
NCT01117181_exc_T38
Qualifier
Clinically significant
NCT01117181_exc_T39
Multiplier
frequency of hallucinations
NCT01117181_exc_T40
Condition
hallucinations
NCT01117181_exc_T41
Measurement
NPI
NCT01117181_exc_T42
Value
Very frequently
NCT01117181_exc_T43
Multiplier
frequency of hallucinations
NCT01117181_exc_T44
Condition
hallucinations
NCT01117181_exc_T45
Measurement
NPI
NCT01117181_exc_T46
Value
Frequently
NCT01117181_exc_T47
Qualifier
severity of the hallucinations
NCT01117181_exc_T48
Condition
hallucinations
NCT01117181_exc_T49
Measurement
NPI
NCT01117181_exc_T50
Value
Moderate
NCT01117181_exc_T51
Value
Marked
NCT01117181_exc_T52
Scope
'Moderate', or 'Marked'
NCT01117181_exc_T53
Scope
frequency of agitation /aggression as assessed by the NPI is 'Very frequently', or 2) the frequency of agitation /aggression as assessed by the NPI is 'Frequently' AND the severity of the agitation as assessed by the NPI is 'Moderate', or 'Marked'
NCT01117181_exc_T54
Scope
frequency of delusions as assessed by the NPI is 'Very frequently', or 2) the frequency of delusions as assessed by the NPI is 'Frequently' AND the severity of the delusions as assessed by the NPI is 'Moderate', or 'Marked'
NCT01117181_exc_T55
Scope
frequency of hallucinations as assessed by the NPI is 'Very frequently', or 2) the frequency of hallucinations as assessed by the NPI is 'Frequently' AND the severity of the hallucinations as assessed by the NPI is 'Moderate', or 'Marked'
NCT01117181_exc_T56
Drug
psychotropic medications
NCT01117181_exc_T57
Temporal
in the 2 weeks prior to randomization
NCT01117181_exc_T58
Reference_point
randomization
NCT01117181_exc_T59
Condition
dementia
NCT01117181_exc_T60
Procedure
treatments for dementia
NCT01117181_exc_T61
Drug
ChEIs
NCT01117181_exc_T62
Drug
memantine
NCT01117181_exc_T63
Scope
ChEIs and memantine
NCT01117181_exc_T64
Drug
selective serotonin reuptake inhibitor antidepressants
NCT01117181_exc_T65
Drug
trazodone
NCT01117181_exc_T66
Negation
with the exception of
NCT01117181_exc_T67
Scope
treatments for dementia (ChEIs and memantine), selective serotonin reuptake inhibitor antidepressants, and trazodone
NCT01117181_exc_T69
Drug
other psychotropics
NCT01117181_exc_T70
Drug
antipsychotics
NCT01117181_exc_T71
Negation
with the exclusion of
NCT01117181_exc_T72
Qualifier
stable
NCT01117181_exc_T73
Temporal
for 3 months
NCT01117181_exc_T74
Drug
methylphenidate
NCT01117181_exc_T75
Drug
methylphenidate
NCT01117181_exc_T77
Drug
medication that would prohibit the safe concurrent use of methylphenidate
NCT01117181_exc_T78
Drug
methylphenidate
NCT01117181_exc_T79
Temporal
concurrent
NCT01117181_exc_T80
Observation
prohibit
NCT01117181_exc_T81
Drug
monoamine oxidase inhibitors
NCT01117181_exc_T82
Drug
tricyclic antidepressants
NCT01117181_exc_T83
Scope
monoamine oxidase inhibitors and tricyclic antidepressants
NCT01117181_exc_T84
Procedure
psychiatric hospitalization
NCT01117181_exc_T85
Observation
Need for
NCT01117181_exc_T86
Temporal
acute
NCT01117181_exc_T87
Condition
suicidal
NCT01117181_exc_T88
Condition
Uncontrolled hypertension
NCT01117181_exc_T89
Qualifier
Uncontrolled
NCT01117181_exc_T90
Condition
medication non-compliance
NCT01117181_exc_T91
Temporal
past 3 months
NCT01117181_exc_T92
Measurement
diastolic reading
NCT01117181_exc_T93
Value
105
NCT01117181_exc_T95
Measurement
compartment pressure of the rectus sheath (CPRS)
NCT01117181_exc_T96
Qualifier
as verified by compartment pressure of the rectus sheath (CPRS)
NCT01117181_exc_T97
Scope
medication non-compliance or past 3 months with a diastolic reading of 105 as verified by compartment pressure of the rectus sheath (CPRS)
NCT01117181_exc_T98
Condition
coronary artery disease
NCT01117181_exc_T99
Qualifier
Symptomatic
NCT01117181_exc_T100
Temporal
at the time of screening
NCT01117181_exc_T101
Reference_point
time of screening
NCT01117181_exc_T102
Condition
unintentional weight loss
NCT01117181_exc_T103
Qualifier
significant
NCT01117181_exc_T105
Condition
Lack of appetite
NCT01117181_exc_T106
Qualifier
as determined by the study physician
NCT01117181_exc_T107
Temporal
in the last three months
NCT01117181_exc_T108
Qualifier
Significant
NCT01117181_exc_T110
Condition
communicative impairments
NCT01117181_exc_T113
Condition
Hyperthyroidism
NCT01117181_exc_T114
Condition
arteriosclerosis
NCT01117181_exc_T115
Qualifier
advanced
NCT01117181_exc_T116
Condition
cardiovascular disease
NCT01117181_exc_T117
Qualifier
symptomatic
NCT01117181_exc_T118
Qualifier
serious
NCT01117181_exc_T119
Condition
structural cardiac abnormalities
NCT01117181_exc_T120
Condition
cardiomyopathy
NCT01117181_exc_T121
Condition
heart rhythm abnormalities
NCT01117181_exc_T122
Qualifier
serious
NCT01117181_exc_T123
Observation
family history
NCT01117181_exc_T124
Condition
sudden death
NCT01117181_exc_T125
Condition
death related to heart problems
NCT01117181_exc_T126
Qualifier
related to heart problems
NCT01117181_exc_T127
Scope
sudden death or death related to heart problems
NCT01117181_exc_T128
Condition
Glaucoma
NCT01117181_exc_T129
Condition
pheochromocytoma
NCT01117181_exc_T130
Condition
hypersensitivity
NCT01117181_exc_T131
Drug
methylphenidate or its excipients
NCT01117181_exc_T132
Drug
its excipients
NCT01117181_exc_T133
Observation
suspected
NCT01117181_exc_T134
Observation
known
NCT01117181_exc_T135
Scope
known or suspected
NCT01117181_exc_T136
Condition
Central Nervous System (CNS) abnormalities
NCT01117181_exc_T137
Condition
cerebral aneurysm
NCT01117181_exc_T138
Condition
vascular abnormalities
NCT01117181_exc_T139
Condition
vasculitis
NCT01117181_exc_T140
Condition
stroke
NCT01117181_exc_T141
Temporal
pre-existing
NCT01117181_exc_T142
Condition
motor tics
NCT01117181_exc_T143
Observation
family history
NCT01117181_exc_T144
Condition
Tourette's syndrome
NCT01117181_exc_T145
Condition
seizures
NCT01117181_exc_T146
Condition
convulsions
NCT01117181_exc_T147
Observation
diagnosis
NCT01117181_exc_T148
Scope
family history or diagnosis
NCT01117181_exc_T149
Condition
epilepsy
NCT01117181_exc_T150
Scope
convulsions, epilepsy
NCT01117181_exc_T151
Qualifier
abnormal
NCT01117181_exc_T152
Condition
EEGs