Trial · NCT02634684
Pharmacologically-augmented Cognitive Therapies (PACTs) for Schizophrenia.
NCT02634684, Phase 2, Completed, University of California, San Diego; results first posted 2021-08-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacologically-augmented Cognitive Therapies (PACTs) for Schizophrenia. Trials, record NCT02634684. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02634684
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacologically-augmented Cognitive Therapies (PACTs) for Schizophrenia.
- NCT number
- NCT02634684
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 82 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- Schizophrenia
- Interventions
- Dextroamphetamine, Placebo
- First posted
- 2015-12-18
- Last updated
- 2021-08-17
- Results first posted
- 2021-08-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Prepulse Inhibition (PPI) | two visits, 1 week apart, each visit lasting approximately 6 hours | 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. |
| Secondary | MATRICS Consensus Cognitive Battery Performance (MCCB) | 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. |
| Secondary | Targeted Cognitive Training (TCT): PositScience, Inc. | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Prepulse Inhibition (PPI) | two visits, 1 week apart, each visit lasting approximately 6 hours | % inhibition of startle | MEAN | |
| SECONDARY | MATRICS Consensus Cognitive Battery Performance (MCCB) | two visits, 1 week apart, each visit lasting approximately 6 hours | standardized T-score | MEAN | |
| SECONDARY | Targeted Cognitive Training (TCT): PositScience, Inc. | two visits, 1 week apart, each visit lasting approximately 6 hours | msec | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Prepulse Inhibition (PPI) | Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine | Placebo | 22.629 | Standard Deviation 62.657 | % inhibition of startle |
| Prepulse Inhibition (PPI) | Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo | Placebo | 41.162 | Standard Deviation 42.103 | % inhibition of startle |
| Prepulse Inhibition (PPI) | Healthy Subjects: Placebo 1st, Then 10 mg Amphetamine | Placebo | 50.626 | Standard Deviation 25.850 | % inhibition of startle |
| Prepulse Inhibition (PPI) | Healthy Subjects: 10 mg Amphetamine 1st, Then Placebo | Placebo | 50.626 | Standard Deviation 29.621 | % inhibition of startle |
| Prepulse Inhibition (PPI) | Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine | Amphetamine | 32.656 | Standard Deviation 57.669 | % inhibition of startle |
| Prepulse Inhibition (PPI) | Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo | Amphetamine | 39.545 | Standard Deviation 33.429 | % inhibition of startle |
| Prepulse Inhibition (PPI) | Healthy Subjects: Placebo 1st, Then 10 mg Amphetamine | Amphetamine | 45.822 | Standard Deviation 31.777 | % inhibition of startle |
| Prepulse Inhibition (PPI) | Healthy Subjects: 10 mg Amphetamine 1st, Then Placebo | Amphetamine | 53.029 | Standard Deviation 24.671 | % inhibition of startle |
| MATRICS Consensus Cognitive Battery Performance (MCCB) | Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine | placebo | 31.895 | Standard Deviation 15.937 | standardized T-score |
| MATRICS Consensus Cognitive Battery Performance (MCCB) | Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo | placebo | 39.895 | Standard Deviation 11.704 | standardized T-score |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine | 19 | |
| Overall Study | STARTED | Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo | 19 | |
| Overall Study | STARTED | Healthy Subjects: Placebo 1st, Then 10 mg Amphetamine | 21 | |
| Overall Study | STARTED | Healthy Subjects: 10 mg Amphetamine 1st, Then Placebo | 23 | |
| Overall Study | COMPLETED | Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine | 19 | |
| Overall Study | COMPLETED | Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo | 19 | |
| Overall Study | COMPLETED | Healthy Subjects: Placebo 1st, Then 10 mg Amphetamine | 21 | |
| Overall Study | COMPLETED | Healthy Subjects: 10 mg Amphetamine 1st, Then Placebo | 23 | |
| Overall Study | NOT COMPLETED | Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine | 0 | |
| Overall Study | NOT COMPLETED | Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Subjects With Schizophrenia: Placebo | 0 | 38 |
| Total, all-cause mortality | Subjects With Schizophrenia: 10 mg Amphetamine | 0 | 38 |
| Total, all-cause mortality | Healthy Subjects: Placebo | 0 | 44 |
| Total, all-cause mortality | Healthy Subjects: 10 mg Amphetamine | 0 | 44 |
| Total, other adverse events | Subjects With Schizophrenia: Placebo | 0 | 38 |
| Total, other adverse events | Subjects With Schizophrenia: 10 mg Amphetamine | 0 | 38 |
| Total, other adverse events | Healthy Subjects: Placebo | 0 | 44 |
| Total, other adverse events | Healthy Subjects: 10 mg Amphetamine | 0 | 44 |
| Total, serious adverse events | Subjects With Schizophrenia: Placebo | 0 | 38 |
| Total, serious adverse events | Subjects With Schizophrenia: 10 mg Amphetamine | 0 | 38 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers31
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH059803 | Pharmacologic augmentation of neurocognition and cognitive training in psychosis | SWERDLOW, NEAL R | UNIVERSITY OF CALIFORNIA, SAN DIEGO | NATIONAL INSTITUTE OF MENTAL HEALTH | 1999 to 2018 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02634684
GET https://conductscience.org/api/trials/v1/NCT02634684/results?page=2