Trial Outcomes & Findings for Nicotinic Enhancement of Cognitive Remediation Training in Schizophrenia (NCT NCT02069392)
NCT ID: NCT02069392
Last Updated: 2019-09-12
Results Overview
The MCCB is an FDA-approved assessment tool for trials of cognition-enhancing treatments in people with schizophrenia. The MCCB is comprised of the following domains: 1) Speed of Processing; 2) Attention/Vigilance; 3) Working Memory; 4) Verbal Learning; 5) Visual Learning; 6) Reasoning and Problem Solving; and 7) Social Cognition. The composite score is standardized to a T-scale (mean=50, standard deviation=10) based on healthy control normative data. Better performance is reflected by higher scores.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
baseline (week 0), weeks 4 and 7 of intervention, end-of-intervention (week 10), 4-week follow-up
Results posted on
2019-09-12
Participant Flow
Participant milestones
| Measure |
Cognitive Remediation Training With Nicotine
Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.
Cognitive remediation training
Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits.
|
Cognitive Remediation Training Without Nicotine
Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.
Cognitive remediation training
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
17
|
|
Overall Study
COMPLETED
|
10
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Cognitive Remediation Training With Nicotine
Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.
Cognitive remediation training
Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits.
|
Cognitive Remediation Training Without Nicotine
Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.
Cognitive remediation training
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
Nicotinic Enhancement of Cognitive Remediation Training in Schizophrenia
Baseline characteristics by cohort
| Measure |
Cognitive Remediation Training With Nicotine
n=14 Participants
Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.
Cognitive remediation training
Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits.
|
Cognitive Remediation Training Without Nicotine
n=17 Participants
Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.
Cognitive remediation training
|
Total
n=31 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
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 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
|
43.0 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Smoking status
Smokers
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Smoking status
Non-smoker
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (week 0), weeks 4 and 7 of intervention, end-of-intervention (week 10), 4-week follow-upThe MCCB is an FDA-approved assessment tool for trials of cognition-enhancing treatments in people with schizophrenia. The MCCB is comprised of the following domains: 1) Speed of Processing; 2) Attention/Vigilance; 3) Working Memory; 4) Verbal Learning; 5) Visual Learning; 6) Reasoning and Problem Solving; and 7) Social Cognition. The composite score is standardized to a T-scale (mean=50, standard deviation=10) based on healthy control normative data. Better performance is reflected by higher scores.
Outcome measures
| Measure |
Cognitive Remediation Training With Nicotine
n=10 Participants
Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.
Cognitive remediation training
Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits.
|
Cognitive Remediation Training Without Nicotine
n=15 Participants
Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.
Cognitive remediation training
|
|---|---|---|
|
MATRICS Consensus Cognitive Battery (MCCB) Composite Score
Baseline
|
32.30 score on a scale
Standard Deviation 15.42
|
33.87 score on a scale
Standard Deviation 10.40
|
|
MATRICS Consensus Cognitive Battery (MCCB) Composite Score
Week 4
|
32.50 score on a scale
Standard Deviation 14.98
|
35.47 score on a scale
Standard Deviation 9.02
|
|
MATRICS Consensus Cognitive Battery (MCCB) Composite Score
Week 7
|
35.30 score on a scale
Standard Deviation 13.70
|
36.87 score on a scale
Standard Deviation 9.75
|
|
MATRICS Consensus Cognitive Battery (MCCB) Composite Score
Week 10 (end of intervention)
|
34.60 score on a scale
Standard Deviation 14.38
|
36.67 score on a scale
Standard Deviation 10.27
|
|
MATRICS Consensus Cognitive Battery (MCCB) Composite Score
4-week follow-up
|
35.00 score on a scale
Standard Deviation 12.67
|
37.87 score on a scale
Standard Deviation 10.14
|
SECONDARY outcome
Timeframe: baseline (week 0) and post-intervention (week 10)Clinician-administered interview about daily life cognitive functioning. The CAI assesses 10 items related to working memory, attention/vigilance, learning/memory, problem solving, processing speed, and social cognition. The total score ranges from 1 (inability to maintain personal hygiene due to cognitive deficits) to 100 (superior cognitive functioning in a wide range of activities). A score of 55 corresponds to moderate cognitive symptoms, e.g. persistent problems paying attention or forgetting scheduled events.
Outcome measures
| Measure |
Cognitive Remediation Training With Nicotine
n=10 Participants
Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.
Cognitive remediation training
Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits.
|
Cognitive Remediation Training Without Nicotine
n=15 Participants
Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.
Cognitive remediation training
|
|---|---|---|
|
Cognitive Assessment Interview (CAI) Score
Baseline
|
55.80 score on a scale
Standard Deviation 12.88
|
59.14 score on a scale
Standard Deviation 9.59
|
|
Cognitive Assessment Interview (CAI) Score
Post-intervention (week 10)
|
69.30 score on a scale
Standard Deviation 12.52
|
64.79 score on a scale
Standard Deviation 10.69
|
SECONDARY outcome
Timeframe: baseline (week 0) and post-intervention (week 10)Semi-structured clinician interview measuring functional outcome and quality of life in people with schizophrenia. Includes subjective questions regarding life satisfaction and objective indicators of social and occupational role functioning during preceding 4 weeks. Seven items are scored on a 0 (severe impairment) to 6 (high functioning) scale. The total score ranges from 0 to 42, with larger values reflecting higher functioning.
Outcome measures
| Measure |
Cognitive Remediation Training With Nicotine
n=10 Participants
Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.
Cognitive remediation training
Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits.
|
Cognitive Remediation Training Without Nicotine
n=15 Participants
Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.
Cognitive remediation training
|
|---|---|---|
|
Change in Abbreviated Schizophrenia Quality of Life Scale Score
Baseline
|
22.30 score on a scale
Standard Deviation 5.70
|
20.29 score on a scale
Standard Deviation 5.99
|
|
Change in Abbreviated Schizophrenia Quality of Life Scale Score
Post-intervention (week 10)
|
24.90 score on a scale
Standard Deviation 5.88
|
23.00 score on a scale
Standard Deviation 4.02
|
SECONDARY outcome
Timeframe: baseline (week 0) and post-intervention (week 10)Measures ability to perform real-life tasks by standardized role-play. Scores reflect percent correct, i.e. range from 0-100 with higher scores representing better performance.
Outcome measures
| Measure |
Cognitive Remediation Training With Nicotine
n=10 Participants
Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.
Cognitive remediation training
Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits.
|
Cognitive Remediation Training Without Nicotine
n=15 Participants
Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.
Cognitive remediation training
|
|---|---|---|
|
UCSD Performance-Based Skills Assessment (UPSA) Score
Baseline
|
77.50 score on a scale
Standard Deviation 14.97
|
71.87 score on a scale
Standard Deviation 14.01
|
|
UCSD Performance-Based Skills Assessment (UPSA) Score
Post-intervention (week 10_
|
75.50 score on a scale
Standard Deviation 14.55
|
74.00 score on a scale
Standard Deviation 12.28
|
SECONDARY outcome
Timeframe: baseline (week 0), post-intervention (week 10)Clinician scale developed to assess the level of depression in schizophrenia. 9 items assess symptoms of depression and overall rater impression on a scale from 0 (absent) to 3 (severe).
Outcome measures
| Measure |
Cognitive Remediation Training With Nicotine
n=10 Participants
Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.
Cognitive remediation training
Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits.
|
Cognitive Remediation Training Without Nicotine
n=15 Participants
Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.
Cognitive remediation training
|
|---|---|---|
|
Calgary Depression Scale Score
Baseline
|
2.40 score on a scale
Standard Deviation 2.45
|
2.07 score on a scale
Standard Deviation 2.28
|
|
Calgary Depression Scale Score
Post-intervention (10 weeks)
|
2.50 score on a scale
Standard Deviation 2.59
|
1.40 score on a scale
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: baseline (week 0), post-intervention (week 10)Clinician rating scale of negative symptoms in schizophrenia. Within each of 5 domains, separate symptoms are rated from 0 (absent) to 5 (severe). Total scores are the sum of 22 subscales and range from 0 to 110, with larger values reflecting higher negative symptoms.
Outcome measures
| Measure |
Cognitive Remediation Training With Nicotine
n=10 Participants
Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.
Cognitive remediation training
Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits.
|
Cognitive Remediation Training Without Nicotine
n=15 Participants
Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.
Cognitive remediation training
|
|---|---|---|
|
Scale for the Assessment of Negative Symptoms (SANS) Score
Baseline
|
36.40 score on a scale
Standard Deviation 11.64
|
37.73 score on a scale
Standard Deviation 7.09
|
|
Scale for the Assessment of Negative Symptoms (SANS) Score
Post-intervention (10 weeks)
|
33.80 score on a scale
Standard Deviation 12.14
|
36.53 score on a scale
Standard Deviation 7.04
|
SECONDARY outcome
Timeframe: baseline (week 0), post-intervention (week 10)Clinician rating scale to measure psychotic symptoms. Each of 20 items is scored 1-7. Total scores are the sum of all items and range from 20 to 140, with larger values reflecting worse symptoms.
Outcome measures
| Measure |
Cognitive Remediation Training With Nicotine
n=10 Participants
Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.
Cognitive remediation training
Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits.
|
Cognitive Remediation Training Without Nicotine
n=15 Participants
Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.
Cognitive remediation training
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS) Score
Baseline
|
39.40 score on a scale
Standard Deviation 9.14
|
37.33 score on a scale
Standard Deviation 7.87
|
|
Brief Psychiatric Rating Scale (BPRS) Score
Post-intervention (10 weeks)
|
39.50 score on a scale
Standard Deviation 9.43
|
36.53 score on a scale
Standard Deviation 5.55
|
SECONDARY outcome
Timeframe: baseline (week 0), post-intervention (week 10), 4-week follow-upSome of the Posit Science exercises provide an assessment tool of training progress on task parameters, which adjust continuously to keep performance at \~85% correct. Enhanced sensory processing speed and precision is considered the central building block of training benefits. Therefore, we analyzed the two exercises aimed at training these processes. Performance is quantified as stimulus presentation time in ms of visual or sound "sweeps", which the participant has to judge in terms of change across space or time. Smaller values reflect better performance. Visual and sound sweeps were averaged.
Outcome measures
| Measure |
Cognitive Remediation Training With Nicotine
n=10 Participants
Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.
Cognitive remediation training
Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits.
|
Cognitive Remediation Training Without Nicotine
n=15 Participants
Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.
Cognitive remediation training
|
|---|---|---|
|
Training Exercise Parameters: Visual and Sound Sweeps
Baseline
|
130.25 ms
Standard Deviation 46.26
|
198.80 ms
Standard Deviation 159.16
|
|
Training Exercise Parameters: Visual and Sound Sweeps
Week 10 (end-of-treatment)
|
94.40 ms
Standard Deviation 28.04
|
124.40 ms
Standard Deviation 73.03
|
|
Training Exercise Parameters: Visual and Sound Sweeps
4-week follow-up
|
102.80 ms
Standard Deviation 39.45
|
117.50 ms
Standard Deviation 69.76
|
SECONDARY outcome
Timeframe: baseline (week 1) and post-intervention (week 10)Derived from a computerized change localization task. One to four colored squares are shown for 100 ms. After a delay, they reappear and the task is to click on the one square that has changed color (50% chance). Performance is expressed as the percentage of correct responses.
Outcome measures
| Measure |
Cognitive Remediation Training With Nicotine
n=10 Participants
Participants complete daily sessions of Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a 2 mg (for non-smokers) or 4 mg (for smokers) nicotine polacrilex lozenge prior to the training.
Cognitive remediation training
Nicotine polacrilex lozenge: Of interest are the effects of nicotine on cognitive remediation training benefits.
|
Cognitive Remediation Training Without Nicotine
n=15 Participants
Participants complete daily Posit Science cognitive remediation training for 10 weeks. Twice a week, participants consume a placebo lozenge prior to the training.
Cognitive remediation training
|
|---|---|---|
|
Change in Working Memory Capacity
Baseline
|
67.7 percentage correct responses
Standard Deviation 16.0
|
67.5 percentage correct responses
Standard Deviation 14.5
|
|
Change in Working Memory Capacity
Post-intervention (10 weeks)
|
67.2 percentage correct responses
Standard Deviation 13.7
|
68.6 percentage correct responses
Standard Deviation 13.7
|
Adverse Events
Cognitive Remediation Training With Nicotine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Remediation Training Without Nicotine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Britta Hahn, Ph.D.
University of Maryland School of Medicine
Phone: 4104026112
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place