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Trial Outcomes & Findings for Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder (NCT NCT00373672)

NCT ID: NCT00373672

Last Updated: 2025-08-05

Results Overview

For the AX-CPT, subjects are required to maintain an attentional set across a delay interval in order to overcome a prepotent response tendency (target responses are required when an X is presented but only in the context of a preceding A; non-target conditions are AY, BX and BY). The dependent measure was d-prime at the long delay (calculated as AX hits minus BX false alarms, which is particularly sensitive to context processing impairments in individuals with schizophrenia.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

58 participants

Primary outcome timeframe

Baseline and week 6

Results posted on

2025-08-05

Participant Flow

Participant milestones

Participant milestones
Measure
ARM + APD
armodafinil (Nuvigil) 150 mg armodafinil (Nuvigil): armodafinil (Nuvigil)150 mg qd
PLC + APD
identical in appearance to active comparator placebo: identical in appearance to active comparator
Overall Study
STARTED
29
29
Overall Study
COMPLETED
29
29
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ARM + APD
n=29 Participants
armodafinil (Nuvigil) 150 mg armodafinil (Nuvigil): armodafinil (Nuvigil)150 mg qd
PLC + APD
n=29 Participants
identical in appearance to active comparator placebo: identical in appearance to active comparator
Total
n=58 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
29 Participants
n=5 Participants
29 Participants
n=7 Participants
58 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
44 years
STANDARD_DEVIATION 14.6 • n=5 Participants
38.8 years
STANDARD_DEVIATION 11.7 • n=7 Participants
41.4 years
STANDARD_DEVIATION 13.15 • n=5 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
9 Participants
n=7 Participants
23 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
20 Participants
n=7 Participants
35 Participants
n=5 Participants
Region of Enrollment
United States
29 Participants
n=5 Participants
29 Participants
n=7 Participants
58 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and week 6

Population: Treatment effects were analyzed using a repeated measures analysis of variance model with time (baseline, 6 weeks) as the within-subjects factor and treatment group (armodafinil, placebo) as the between-subjects factor.

For the AX-CPT, subjects are required to maintain an attentional set across a delay interval in order to overcome a prepotent response tendency (target responses are required when an X is presented but only in the context of a preceding A; non-target conditions are AY, BX and BY). The dependent measure was d-prime at the long delay (calculated as AX hits minus BX false alarms, which is particularly sensitive to context processing impairments in individuals with schizophrenia.

Outcome measures

Outcome measures
Measure
ARM + APD
n=29 Participants
armodafinil (Nuvigil) 150 mg armodafinil (Nuvigil): armodafinil (Nuvigil)150 mg qd
PLC + APD
n=29 Participants
identical in appearance to active comparator placebo: identical in appearance to active comparator
Cognition Measured by AX-Continuous Performance Test (AX-CPT) D-prime Score
Baseline
2.7 d prime score
Standard Error 0.3
2.5 d prime score
Standard Error 0.3
Cognition Measured by AX-Continuous Performance Test (AX-CPT) D-prime Score
6 weeks
2.3 d prime score
Standard Error 0.4
3.2 d prime score
Standard Error 0.4

Adverse Events

ARM + APD

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

PLC + APD

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
ARM + APD
n=29 participants at risk
armodafinil (Nuvigil) 150 mg armodafinil (Nuvigil): armodafinil (Nuvigil)150 mg qd
PLC + APD
n=29 participants at risk
identical in appearance to active comparator placebo: identical in appearance to active comparator
Nervous system disorders
worsening of psychiatric symptoms
3.4%
1/29 • Number of events 1
0.00%
0/29

Additional Information

Herbert Y Meltzer

Northwestern University

Phone: 1 312 503 0309

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place