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Trial Outcomes & Findings for Predictors of Response to Cognitive Remediation in Schizophrenia (NCT NCT00333970)

NCT ID: NCT00333970

Last Updated: 2014-10-09

Results Overview

Change in verbal memory scores from baseline to end of active phase (2 months), measured as trials 1-5 total score on the California Verbal Learning Test -II (range 0-80, higher scores represent better performance).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

103 participants

Primary outcome timeframe

baseline and 2 months

Results posted on

2014-10-09

Participant Flow

103 participants were enrolled. Of those, 75 were found eligible, completed baseline assessments and were then randomized to either Arm 1 (n=50) or Arm 2 (n=25). The remaining 28 participants were either discontinued from the study by the PI or chose to withdraw prior to randomization.

Participant milestones

Participant milestones
Measure
Arm 1
cognitive remediation cognitive remediation: individual cognitive training
Arm 2
treatment as usual
Overall Study
STARTED
50
25
Overall Study
COMPLETED
37
18
Overall Study
NOT COMPLETED
13
7

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm 1
cognitive remediation cognitive remediation: individual cognitive training
Arm 2
treatment as usual
Overall Study
Withdrawal by Subject
13
7

Baseline Characteristics

Predictors of Response to Cognitive Remediation in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm 1
n=50 Participants
cognitive remediation cognitive remediation: individual cognitive training
Arm 2
n=25 Participants
treatment as usual
Total
n=75 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
50 Participants
n=5 Participants
25 Participants
n=7 Participants
75 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
9 Participants
n=7 Participants
19 Participants
n=5 Participants
Sex: Female, Male
Male
40 Participants
n=5 Participants
16 Participants
n=7 Participants
56 Participants
n=5 Participants

PRIMARY outcome

Timeframe: baseline and 2 months

Population: individuals who were randomized and completed 2 month assessments

Change in verbal memory scores from baseline to end of active phase (2 months), measured as trials 1-5 total score on the California Verbal Learning Test -II (range 0-80, higher scores represent better performance).

Outcome measures

Outcome measures
Measure
Arm 1
n=39 Participants
cognitive remediation cognitive remediation: individual cognitive training
Arm 2
n=23 Participants
treatment as usual
Cognitive Performance
4.97 units on a scale
Standard Error 1.38
-2.30 units on a scale
Standard Error 1.98

Adverse Events

Arm 1

Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths

Arm 2

Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Arm 1
n=50 participants at risk
cognitive remediation cognitive remediation: individual cognitive training
Arm 2
n=50 participants at risk；n=25 participants at risk
treatment as usual
Respiratory, thoracic and mediastinal disorders
shortness of breath
0.00%
0/50
4.0%
1/25 • Number of events 1
Musculoskeletal and connective tissue disorders
pulled chest muscle
0.00%
0/50
4.0%
1/25 • Number of events 1
Psychiatric disorders
worsening of psychiatric symptoms
2.0%
1/50 • Number of events 1
0.00%
0/25
Psychiatric disorders
substance abuse
2.0%
1/50 • Number of events 1
0.00%
0/25
Renal and urinary disorders
renal failure
2.0%
1/50 • Number of events 1
0.00%
0/25

Other adverse events

Other adverse events
Measure
Arm 1
n=50 participants at risk
cognitive remediation cognitive remediation: individual cognitive training
Arm 2
n=50 participants at risk；n=25 participants at risk
treatment as usual
Psychiatric disorders
worsening of psychiatric symptoms
4.0%
2/50 • Number of events 2
8.0%
2/25 • Number of events 2
Psychiatric disorders
substance use
0.00%
0/50
12.0%
3/25 • Number of events 3
General disorders
dizziness
2.0%
1/50 • Number of events 1
0.00%
0/25
Injury, poisoning and procedural complications
toe pain
2.0%
1/50 • Number of events 1
0.00%
0/25

Additional Information

Dr. Joanna Fiszdon

VA Connecticut Healthcare System

Phone: 203-932-5711

Results disclosure agreements

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