Trial Outcomes & Findings for Treating Cognition in Schizophrenia With Atomoxetine and Cognitive Remediation (NCT NCT00628394)
NCT ID: NCT00628394
Last Updated: 2020-09-25
Results Overview
Gordon Continuous Performance Test - Distractibility Version The test is designed assess a person's executive functioning by testing their ability to maintain their focus over a period of time. They are intended to respond to a series of targets or inhibit their responses to a variety of foils. They are mainly assessed for their omissions and commissions. The omission and commission errors assess the person's ability to screen out extraneous stimuli while responding correctly and inhibiting incorrect responding. This means lower scores are better. The scale is 0-126.
COMPLETED
PHASE4
119 participants
12 weeks
2020-09-25
Participant Flow
Some participants were never randomized due to Screening labs, illicit substances (repeatedly - exclusion), transportation issues, or simply being lost to follow-up. Lost to f/u were contacted 3 times and sent a letter in order to bring them back into the study.
Participant milestones
| Measure |
Atomox/CR
Patients are given the drug Atomoxetine and Cognitive Remediation training.
Atomoxetine: 40mg 2po qam
|
Atomox/Control
Patients are given the drug Atomoxetine and Remediation Control training.
Atomoxetine: 40mg 2po qam
|
Placebo/CR
Patients are given a Placebo and Cognitive Remediation training.
Placebo: 40mg 2po qam
|
Placebo/Control
Patients are given Placebo and Remediation Control training.
Placebo: 40mg 2po qam
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
13
|
13
|
|
Overall Study
COMPLETED
|
10
|
9
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treating Cognition in Schizophrenia With Atomoxetine and Cognitive Remediation
Baseline characteristics by cohort
| Measure |
Atomox/CR
n=10 Participants
Patients are given the drug Atomoxetine and Cognitive Remediation training.
Atomoxetine: 40mg 2po qam
|
Atomox/Control
n=9 Participants
Patients are given the drug Atomoxetine and Remediation Control training.
Atomoxetine: 40mg 2po qam
|
Placebo/CR
n=11 Participants
Patients are given a Placebo and Cognitive Remediation training.
Placebo: 40mg 2po qam
|
Placebo/Control
n=10 Participants
Patients are given Placebo and Remediation Control training.
Placebo: 40mg 2po qam
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
40 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
29 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
11 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
38 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
17 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
23 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=39 Participants
|
9 participants
n=41 Participants
|
11 participants
n=35 Participants
|
10 participants
n=31 Participants
|
40 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 12 weeksGordon Continuous Performance Test - Distractibility Version The test is designed assess a person's executive functioning by testing their ability to maintain their focus over a period of time. They are intended to respond to a series of targets or inhibit their responses to a variety of foils. They are mainly assessed for their omissions and commissions. The omission and commission errors assess the person's ability to screen out extraneous stimuli while responding correctly and inhibiting incorrect responding. This means lower scores are better. The scale is 0-126.
Outcome measures
| Measure |
Atomox/CR
n=10 Participants
Patients are given the drug Atomoxetine and Cognitive Remediation training.
Atomoxetine: 40mg 2po qam
|
Atomox/Control
n=9 Participants
Patients are given the drug Atomoxetine and Remediation Control training.
Atomoxetine: 40mg 2po qam
|
Placebo/CR
n=11 Participants
Patients are given a Placebo and Cognitive Remediation training.
Placebo: 40mg 2po qam
|
Placebo/Control
n=10 Participants
Patients are given Placebo and Remediation Control training.
Placebo: 40mg 2po qam
|
|---|---|---|---|---|
|
Neuropsychological Measures for MATRICS
|
20.82 score on a scale
Standard Deviation 1.71
|
18.03 score on a scale
Standard Deviation 1.77
|
25.43 score on a scale
Standard Deviation 1.64
|
11.64 score on a scale
Standard Deviation 1.70
|
SECONDARY outcome
Timeframe: 12 weeksBirchwood Social Function Scale (SFS) This scale is given to determine a person's ability to function independently and in social settings without difficulty. It assesses a variety of settings with independent subscales (whose scores vary in range) but in which the higher score is always better. These subscales (Withdrawal/Social Engagement; Interpersonal Communication; Independence-Performance; Independence-Competence; Recreation; Prosocial; and, Employment/Occupation) are combined and developed into a mean score. These scores range from 0-32.
Outcome measures
| Measure |
Atomox/CR
n=10 Participants
Patients are given the drug Atomoxetine and Cognitive Remediation training.
Atomoxetine: 40mg 2po qam
|
Atomox/Control
n=9 Participants
Patients are given the drug Atomoxetine and Remediation Control training.
Atomoxetine: 40mg 2po qam
|
Placebo/CR
n=11 Participants
Patients are given a Placebo and Cognitive Remediation training.
Placebo: 40mg 2po qam
|
Placebo/Control
n=10 Participants
Patients are given Placebo and Remediation Control training.
Placebo: 40mg 2po qam
|
|---|---|---|---|---|
|
Clinical Outcomes
|
9.75 units on a scale
Standard Deviation .37
|
10.32 units on a scale
Standard Deviation .39
|
10.82 units on a scale
Standard Deviation .36
|
9.02 units on a scale
Standard Deviation .38
|
Adverse Events
Atomox/CR
Atomox/Control
Placebo/CR
Placebo/Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atomox/CR
n=10 participants at risk
Patients are given the drug Atomoxetine and Cognitive Remediation training.
Atomoxetine: 40mg 2po qam
|
Atomox/Control
n=9 participants at risk
Patients are given the drug Atomoxetine and Remediation Control training.
Atomoxetine: 40mg 2po qam
|
Placebo/CR
n=11 participants at risk
Patients are given a Placebo and Cognitive Remediation training.
Placebo: 40mg 2po qam
|
Placebo/Control
n=10 participants at risk
Patients are given Placebo and Remediation Control training.
Placebo: 40mg 2po qam
|
|---|---|---|---|---|
|
Psychiatric disorders
Decreased appetite
|
30.0%
3/10 • Number of events 3
|
22.2%
2/9 • Number of events 2
|
0.00%
0/11
|
0.00%
0/10
|
Additional Information
Carol A. Tamminga, MD
University of Texas Southwestern Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place