Study of the Effects of Mecamylamine and Varenicline in Schizophrenia
NCT00455650, Not applicable, Completed, Massachusetts General Hospital; results first posted 2017-03-28
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Study of the Effects of Mecamylamine and Varenicline in Schizophrenia | ClinicalTrials.gov |
| NCT number | NCT00455650 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 89 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Massachusetts General Hospital | ClinicalTrials.gov |
| Conditions | Cognition in Schizophrenia | ClinicalTrials.gov |
| Interventions | Mecamylamine, Varenicline, Placebo | ClinicalTrials.gov |
| First posted | 2007-04-04 | ClinicalTrials.gov |
| Last updated | 2017-03-28 | ClinicalTrials.gov |
| Results first posted | 2017-03-28 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability | Baseline (week 0), week 1, week 2 and week 3 as one time point (see outcome measure description) | The Continuous Performance Test-Identical Pairs, CPT-IP, Version 4.0 was developed and normed for use in people with schizophrenia and normal controls. This task estimates attention by requiring an individual to push a response key when two identical pairs of shapes or numbers are presented in sequence. Stimuli were presented with increasing cognitive load: 2-, 3-, and 4-digit targets. Outcome variables measured included correct hits, hit reaction time (HRT), errors of commission: false alarms and random errors, and the primary outcome, variability, or standard deviation, of hit reaction time, HRT-SD. There is only one outcome measure time point because cognitive outcomes were analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors. | ClinicalTrials.gov |
| Secondary | Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Cognitive Interference as Assessed by The Three-card Stroop Task | Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point | In the 3-card Stroop Task, 3 cards were presented; the 1st contained color names printed in black ink, the 2nd contained colored patches of ink, the 3rd contained color names printed in incongruously colored ink. Participants were asked to read or name as many items as possible in 45 seconds for each condition. Individuals are asked to identify the color of the ink of a word. They may be distracted by the presence of a word that states another color (i.e. the word "blue" written in green ink would require the answer green).The interference score was calculated by dividing the color-word score by the color score. There is only one outcome measure time point because cognitive outcomes were analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs varenicline vs pbo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor as well as study period and drug administration sequence as between subject crossover design factors | ClinicalTrials.gov |
| Secondary | Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task | Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point | The N-back task with 1- and 2-back parametric conditions was used. During the task, a letter was displayed for 1,500 ms every 2 s with a 500 ms isi. Participants were asked to press the "1" key for letters that corresponded to the letter 1 back for the 1-back condition, the "2" key for the 2-back condition, and the "3" key for nontarget letters. Outcome variable presented is hit reaction time There is only one outcome measure time point because this outcome was analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors. | ClinicalTrials.gov |
| Secondary | Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Working Memory as Assessed by The Visual Spatial Working Memory (VSWM) Task | Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point | In the Visual spatial working memory (VSWM), participants were asked to place the cursor where the symbol appeared immediately after its display. For 16 additional trials, participants were asked to identify the symbol location after a 30-second delay. During the delay, participants were distracted by being asked to read aloud words appearing on the screen at 2-second intervals. The outcome of interest in this task were the average distance from the target for immediate and delayed recall There is only one outcome measure time frame because this outcome was analyzed using crossover analyses of covariance (ANCOVA) with drug (mecamylamine vs. varenicline vs. placebo) as a within subject factor, diagnosis (schizophrenia vs. control) as a between subject factor, as well as study period and drug administration sequence as between subject crossover design factors. | ClinicalTrials.gov |
Outcomes 4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability | Baseline (week 0), week 1, week 2 and week 3 as one time point (see outcome measure description) | ms | MEAN | ClinicalTrials.gov | |
| SECONDARY | Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Cognitive Interference as Assessed by The Three-card Stroop Task | Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point | score | MEAN | ClinicalTrials.gov | |
| SECONDARY | Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task | Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point | ms | MEAN | ClinicalTrials.gov | |
| SECONDARY | Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Working Memory as Assessed by The Visual Spatial Working Memory (VSWM) Task | Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point | Distance (in) | MEAN | ClinicalTrials.gov |
Results by group 24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability | Schizophrenia: Mecamylamine | 141.6 | Standard Deviation 57.5 | ms | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability | Schizophrenia: Varenicline | 120.5 | Standard Deviation 58.5 | ms | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability | Schizophrenia: Placebo | 123.1 | Standard Deviation 44.9 | ms | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability | Control: Mecamylamine | 91.2 | Standard Deviation 31.1 | ms | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability | Control: Varenicline | 83.2 | Standard Deviation 30.2 | ms | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Prolonged Attention as Assessed With the CPT-IP Hit Reaction Time Variability | Control: Placebo | 87.8 | Standard Deviation 21.7 | ms | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Cognitive Interference as Assessed by The Three-card Stroop Task | Schizophrenia: Mecamylamine | 50.2 | Standard Deviation 6.8 | score | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Cognitive Interference as Assessed by The Three-card Stroop Task | Schizophrenia: Varenicline | 52.8 | Standard Deviation 8.0 | score | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Cognitive Interference as Assessed by The Three-card Stroop Task | Schizophrenia: Placebo | 50.3 | Standard Deviation 8.3 | score | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Cognitive Interference as Assessed by The Three-card Stroop Task | Control: Mecamylamine | 54.4 | Standard Deviation 10.5 | score | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Cognitive Interference as Assessed by The Three-card Stroop Task | Control: Varenicline | 53.3 | Standard Deviation 9.2 | score | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Cognitive Interference as Assessed by The Three-card Stroop Task | Control: Placebo | 53.5 | Standard Deviation 8.6 | score | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task | Schizophrenia: Mecamylamine | 909.2 | Standard Deviation 250.9 | ms | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task | Schizophrenia: Varenicline | 931.2 | Standard Deviation 297.9 | ms | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task | Schizophrenia: Placebo | 894.4 | Standard Deviation 282.1 | ms | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task | Control: Mecamylamine | 864.6 | Standard Deviation 253.9 | ms | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task | Control: Varenicline | 795.8 | Standard Deviation 241.7 | ms | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task | Control: Placebo | 827.5 | Standard Deviation 229.3 | ms | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Working Memory as Assessed by The Visual Spatial Working Memory (VSWM) Task | Schizophrenia: Mecamylamine | 2.83 | Standard Deviation 0.71 | Distance (in) | ClinicalTrials.gov | |
| Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Working Memory as Assessed by The Visual Spatial Working Memory (VSWM) Task | Schizophrenia: Varenicline | 2.72 | Standard Deviation 0.66 | Distance (in) | ClinicalTrials.gov |
Participant flow 54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Week 1 | STARTED | Schizoph: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3) | 10 | ClinicalTrials.gov | |
| Week 1 | STARTED | Schizoph: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3) | 10 | ClinicalTrials.gov | |
| Week 1 | STARTED | Schizoph: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3) | 10 | ClinicalTrials.gov | |
| Week 1 | STARTED | Control: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3) | 14 | ClinicalTrials.gov | |
| Week 1 | STARTED | Control: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3) | 14 | ClinicalTrials.gov | |
| Week 1 | STARTED | Control: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3) | 13 | ClinicalTrials.gov | |
| Week 1 | COMPLETED | Schizoph: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3) | 10 | ClinicalTrials.gov | |
| Week 1 | COMPLETED | Schizoph: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3) | 10 | ClinicalTrials.gov | |
| Week 1 | COMPLETED | Schizoph: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3) | 10 | ClinicalTrials.gov | |
| Week 1 | COMPLETED | Control: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3) | 14 | ClinicalTrials.gov | |
| Week 1 | COMPLETED | Control: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3) | 14 | ClinicalTrials.gov | |
| Week 1 | COMPLETED | Control: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3) | 13 | ClinicalTrials.gov | |
| Week 1 | NOT COMPLETED | Schizoph: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3) | 0 | ClinicalTrials.gov | |
| Week 1 | NOT COMPLETED | Schizoph: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3) | 0 | ClinicalTrials.gov | |
| Week 1 | NOT COMPLETED | Schizoph: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3) | 0 | ClinicalTrials.gov | |
| Week 1 | NOT COMPLETED | Control: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3) | 0 | ClinicalTrials.gov | |
| Week 1 | NOT COMPLETED | Control: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3) | 0 | ClinicalTrials.gov | |
| Week 1 | NOT COMPLETED | Control: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3) | 0 | ClinicalTrials.gov | |
| Week 2 | STARTED | Schizoph: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3) | 10 | ClinicalTrials.gov | |
| Week 2 | STARTED | Schizoph: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3) | 10 | ClinicalTrials.gov |
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Schizophrenia | ClinicalTrials.gov | ||
| Total, all-cause mortality | Control | ClinicalTrials.gov | ||
| Total, other adverse events | Schizophrenia | 0 | 30 | ClinicalTrials.gov |
| Total, other adverse events | Control | 0 | 41 | ClinicalTrials.gov |
| Total, serious adverse events | Schizophrenia | 0 | 30 | ClinicalTrials.gov |
| Total, serious adverse events | Control | 0 | 41 | ClinicalTrials.gov |
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 24114425 | RESULT | PubMed |
Grants 0
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 | Source |
|---|
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Schizophrenia vs Control: serious adverse events | Trial comparisons |
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Continuous Performance Test | Primary outcome | ConductCognition |
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)