Trial Outcomes & Findings for Pharmacologically-augmented Cognitive Therapies (PACTs) for Schizophrenia. (NCT NCT02634684)

Last Updated: 2021-08-17

Results Overview

PPI was assessed with 42 trials of 6 types: 118 dB 40 ms pulse alone (P) \& the same P preceded 10, 20, 30, 60, or 120 ms by a prepulse (pp) 16 dB over background. Startle magnitude (SM), habituation, latency \& latency facilitation were measured to interpret changes in PPI. %PPI = 100 x \[(SM on P trials) - (SM on pp+P trials)\] / SM on P trials. Example: SM on P trials = 80 units SM on pp+P trials = 30 units %PPI = 100 x (80-30)/80 = 100 x 50/80 = 62.5% Greater %PPI mean the reflex has been inhibited to a greater extent in the presence of a pp. %PPI can't exceed 100: when SM on pp+P trials = 0, then %PPI = 100 x (SM on P trials - 0)/SM on P trials = 100 x 1 = 100%. However, %PPI can theoretically be infinitely negative since SM on pp+P trials could be infinitely large ("prepulse facilitiation" (PPF)), i.e. SM is potentiated in the presence of a pp. PPF is "normal" at very short \& very long pp intervals, but not within a species-specific physiological range of intervals.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

82 participants

Primary outcome timeframe

two visits, 1 week apart, each visit lasting approximately 6 hours

Results posted on

2021-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Healthy Subjects: Placebo 1st, Then 10 mg Amphetamine Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Healthy Subjects: 10 mg Amphetamine 1st, Then Placebo Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
Overall Study STARTED	19	19	21	23
Overall Study COMPLETED	19	19	21	23
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacologically-augmented Cognitive Therapies (PACTs) for Schizophrenia.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine n=19 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo n=19 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Healthy Subjects: Placebo 1st, Then 10 mg Amphetamine n=21 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Healthy Subjects: 10 mg Amphetamine 1st, Then Placebo n=23 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Total n=82 Participants Total of all reporting groups
Age, Continuous	39 years n=5 Participants	42 years n=7 Participants	29 years n=5 Participants	30 years n=4 Participants	35 years n=21 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	29 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	17 Participants n=4 Participants	53 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	24 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	18 Participants n=4 Participants	52 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	15 Participants n=21 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	12 Participants n=4 Participants	31 Participants n=21 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment United States	19 participants n=5 Participants	19 participants n=7 Participants	21 participants n=5 Participants	23 participants n=4 Participants	82 participants n=21 Participants

PRIMARY outcome

Timeframe: two visits, 1 week apart, each visit lasting approximately 6 hours

Outcome measures

Outcome measures
Measure	Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine n=19 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo n=19 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Healthy Subjects: Placebo 1st, Then 10 mg Amphetamine n=21 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Healthy Subjects: 10 mg Amphetamine 1st, Then Placebo n=23 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
Prepulse Inhibition (PPI) Placebo	22.629 % inhibition of startle Standard Deviation 62.657	41.162 % inhibition of startle Standard Deviation 42.103	50.626 % inhibition of startle Standard Deviation 25.850	50.626 % inhibition of startle Standard Deviation 29.621
Prepulse Inhibition (PPI) Amphetamine	32.656 % inhibition of startle Standard Deviation 57.669	39.545 % inhibition of startle Standard Deviation 33.429	45.822 % inhibition of startle Standard Deviation 31.777	53.029 % inhibition of startle Standard Deviation 24.671

SECONDARY outcome

Timeframe: two visits, 1 week apart, each visit lasting approximately 6 hours

The T-score indicates the performance on a neurocognitive battery of tests. Higher score reflects better performance.

Outcome measures

Outcome measures
Measure	Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine n=19 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo n=19 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Healthy Subjects: Placebo 1st, Then 10 mg Amphetamine n=21 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Healthy Subjects: 10 mg Amphetamine 1st, Then Placebo n=23 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
MATRICS Consensus Cognitive Battery Performance (MCCB) placebo	31.895 standardized T-score Standard Deviation 15.937	39.895 standardized T-score Standard Deviation 11.704	54.476 standardized T-score Standard Deviation 11.557	57.870 standardized T-score Standard Deviation 11.153
MATRICS Consensus Cognitive Battery Performance (MCCB) amphetamine	33.842 standardized T-score Standard Deviation 16.269	38.105 standardized T-score Standard Deviation 12.552	55.476 standardized T-score Standard Deviation 11.383	56.000 standardized T-score Standard Deviation 11.286

SECONDARY outcome

Timeframe: two visits, 1 week apart, each visit lasting approximately 6 hours

Auditory discrimination learning: Subjects identify direction (up vs. down) of 2 consecutive sound sweeps. Parameters (e.g. inter-sweep interval, sweep duration) are established for subjects to maintain 80% correct responses. On screen and test days, subjects complete 1h of TCT. Analytic software yields the key measures: auditory processing speed (APS) and APS "learning". APS is the shortest inter-stimulus interval at which a subject performs to criteria and APS learning is the difference (ms) between the first APS and the best APS of the subsequent trials. A smaller APS reflects "better" discrimination (i.e., subject correctly identified frequency "sweep" direction despite a smaller ms gap between stimuli) and a larger ms value for APS learning reflects more learning, i.e., faster APS with repeated trials. Limits for APS are capped at 0-to-1000 ms; values for APS learning are capped at (-) 1000-to-APS.

Outcome measures

Outcome measures
Measure	Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine n=19 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo n=19 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Healthy Subjects: Placebo 1st, Then 10 mg Amphetamine n=21 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.	Healthy Subjects: 10 mg Amphetamine 1st, Then Placebo n=23 Participants Drug: Dexedrine, dextroamphetamine, d-amphetamine. Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (dextroamphetamine) 30 minutes after arriving at the lab. The participant then completes \~6 hours of testing in the laboratory. The participant stays at the lab for \~7.5 hours to monitor physical condition in case the participant received the active pill. One week later, the participant receives a single pill of comparator and is again tested in the laboratory. Total of 1 visits, approximately 1 week apart; in total, each participant receives one placebo pill and 1 active pill separated by one week. Dextroamphetamine: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week. Placebo: Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
Targeted Cognitive Training (TCT): PositScience, Inc. placebo	-15.118 msec Standard Deviation 346.088	-50.158 msec Standard Deviation 218.464	5.911 msec Standard Deviation 75.105	-2.113 msec Standard Deviation 107.563
Targeted Cognitive Training (TCT): PositScience, Inc. amphetamine	52.647 msec Standard Deviation 305.887	101.000 msec Standard Deviation 434.379	35.905 msec Standard Deviation 64.539	29.190 msec Standard Deviation 83.183

Adverse Events

Subjects With Schizophrenia: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subjects With Schizophrenia: 10 mg Amphetamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Subjects: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Subjects: 10 mg Amphetamine

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

Neal Swerdlow, M.D., Ph.D.

UC San Diego

Phone: 619-543-6270

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place