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Study of the Effects of Mecamylamine and Varenicline in Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
The Bowman Family Foundation
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00455650
First received: April 2, 2007
Last updated: February 7, 2017
Last verified: February 2017
Results First Received: September 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Cognition in Schizophrenia
Interventions: Drug: Mecamylamine
Drug: Varenicline
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were stable, outpatient, non-smokers with schizophrenia on a stable dose of antipsychotic medication for at least 4 wks, from an urban community mental health clinic in Boston. Controls were recruited through media advertisements in the greater Boston area and had no lifetime history of Axis I disorders by SCID

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
89 participants were enrolled, 71 participants (30 patients, 41 controls) completed at least one medication visit and were included in the analyses. 4 participants (3 with schizophrenia, 1 control) missed one and 5 participants (3 with schizophrenia, 2 controls) missed 2 of the 3 medication visits.

Reporting Groups
  Description
Schizoph: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3) Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
Schizoph: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3) Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
Schizoph: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3) Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
Control: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3) Mecamylamine: A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
Control: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3) Varenicline: A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
Control: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3) Placebo: The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.

Participant Flow for 3 periods

Period 1:   Week 1
    Schizoph: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)   Schizoph: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)   Schizoph: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)   Control: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)   Control: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)   Control: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)
STARTED   10   10   10   14   14   13 
COMPLETED   10   10   10   14   14   13 
NOT COMPLETED   0   0   0   0   0   0 

Period 2:   Week 2
    Schizoph: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)   Schizoph: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)   Schizoph: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)   Control: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)   Control: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)   Control: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)
STARTED   10   10   10   14   14   13 
COMPLETED   10   10   10   14   14   13 
NOT COMPLETED   0   0   0   0   0   0 

Period 3:   Week 3
    Schizoph: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)   Schizoph: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)   Schizoph: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)   Control: Mecamylamine (Wk1),Varenicline (Wk2), Placebo (Wk3)   Control: Placebo (Wk1), Mecamylamine (Wk2), Varenicline (Wk3)   Control: Varenicline (Wk1), Placebo (Wk2), Mecamylamine (Wk3)
STARTED   10   10   10   14   14   13 
COMPLETED   10   10   10   14   14   13 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eighty-nine participants were enrolled, and 71 participants (30 patients, 41 controls) completed at least one medication visit and were included in the analyses. Four participants (3 with schizophrenia, 1 control) missed one and 5 participants (3 with schizophrenia, 2 controls) missed two of the three medication visits.

Reporting Groups
  Description
Schizophrenia Study participants in the schizophrenia group were clinically stable, outpatient, non-smokers with schizophrenia on a stable, clinically determined dose of antipsychotic medication for at least 4 weeks, which were recruited from an urban community mental health clinic in Boston. Diagnoses were confirmed by clinical interview and medical record review
Control Healthy volunteers were recruited through media advertisements in the greater Boston area and had no lifetime history of Axis I disorders by SCID interview and no firstdegree relatives with Axis I disorders by history
Total Total of all reporting groups

Baseline Measures
   Schizophrenia   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   41   71 
Age 
[Units: Years]
Mean (Standard Deviation)
 47  (10)   37  (16)   42  (13) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  33.3%      23  56.1%      33  46.5% 
Male      20  66.7%      18  43.9%      38  53.5% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   24   22   46 
African American   5   12   17 
Asian or Pacific Islander   0   4   4 
Unknown   1   3   4 
Region of Enrollment 
[Units: Participants]
     
United States   30   41   71 


  Outcome Measures
  Show All Outcome Measures

1.  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   [ Time Frame: Baseline (week 0), week 1, week 2 and week 3 as one time point (see outcome measure description) ]

2.  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   [ Time Frame: Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point ]

3.  Secondary:   Effects of Mecamylamine and Varenicline Compared With Placebo in Schizophrenia and Control Groups on Sustained Attention as Assessed by The N-back Task   [ Time Frame: Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point ]

4.  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   [ Time Frame: Baseline (week 1), week 2, week 3, week 4 analyzed as a single time point ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: A. Eden Evins, MD, MPH
Organization: Massachusetts General Hospital
phone: 617-643-4679
e-mail: aeevins@mgh.harvard.edu


Publications of Results:

Responsible Party: A. Eden Evins, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00455650     History of Changes
Other Study ID Numbers: PHRC #2006-P-001361
CORRC#3-2007
Study First Received: April 2, 2007
Results First Received: September 22, 2016
Last Updated: February 7, 2017