MedDataX Logo

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

119 participants

Primary outcome timeframe

12 weeks

Results posted on

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

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

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=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=5 Participants
9 Participants
n=7 Participants
11 Participants
n=5 Participants
10 Participants
n=4 Participants
40 Participants
n=21 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
6 Participants
n=7 Participants
7 Participants
n=5 Participants
8 Participants
n=4 Participants
29 Participants
n=21 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
2 Participants
n=4 Participants
11 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
2 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
n=5 Participants
9 Participants
n=7 Participants
11 Participants
n=5 Participants
9 Participants
n=4 Participants
38 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
2 Participants
n=7 Participants
7 Participants
n=5 Participants
5 Participants
n=4 Participants
17 Participants
n=21 Participants
Race (NIH/OMB)
White
7 Participants
n=5 Participants
7 Participants
n=7 Participants
4 Participants
n=5 Participants
5 Participants
n=4 Participants
23 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Region of Enrollment
United States
10 participants
n=5 Participants
9 participants
n=7 Participants
11 participants
n=5 Participants
10 participants
n=4 Participants
40 participants
n=21 Participants

PRIMARY outcome

Timeframe: 12 weeks

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.

Outcome measures

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 weeks

Birchwood 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

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

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

Atomox/Control

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

Placebo/CR

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

Placebo/Control

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
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

Phone: 214-645-2789

Results disclosure agreements

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