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Systematic Evaluation of Antiviral Medication in Schizophrenia (SEAMS)

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ClinicalTrials.gov Identifier: NCT00514449
Recruitment Status : Completed
First Posted : August 10, 2007
Results First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
Stanley Medical Research Institute
Wayne State University
Information provided by (Responsible Party):
Konasale Prasad, University of Pittsburgh

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Drug: Valacyclovir
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited between 7/2007 and 8/2009 at two separate sites, Pittsburgh and Detroit. Recruitment took place through the local hospital and community mental health and school counseling centers, as well as other research studies and area mental health conferences.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients first had a placebo run-in for two weeks along with the psychiatric medications they were on and then randomized at Week 2 to either VAV or placebo group. Enrolled subjects were excluded due to cannabis abuse, claustrophobia, and a duration of illness that was too long.

Reporting Groups
  Description
Valacyclovir 1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
Sugar Pill 2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.

Participant Flow:   Overall Study
    Valacyclovir   Sugar Pill
STARTED   12   12 
COMPLETED   9   8 
NOT COMPLETED   3   4 
Withdrawal by Subject                1                2 
Protocol Violation                1                2 
Lost to Follow-up                1                0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Valacyclovir 1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
Sugar Pill 2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
Total Total of all reporting groups

Baseline Measures
   Valacyclovir   Sugar Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      12 100.0%      12 100.0%      24 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.6  (9.4)   28.7  (8.5)   29.2  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  50.0%      5  41.7%      11  45.8% 
Male      6  50.0%      7  58.3%      13  54.2% 
Region of Enrollment 
[Units: Participants]
     
United States   12   12   24 


  Outcome Measures

1.  Primary:   PANSS Positive and Negative Syndrome Scale for Schizophrenia   [ Time Frame: Baseline, Weeks 2, 4, 6, 10, 14, 18 ]

2.  Primary:   Cognitive Function Neuropsychological Battery (Gur Battery)   [ Time Frame: Baseline, Week 18 ]

3.  Secondary:   Changes in Grey Matter Deficit   [ Time Frame: Baseline, Week 18 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
This was a small sample study designed as a proof of concept. A larger study will follow.


  More Information

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: Dr. Konasale Prasad
Organization: Western Psychiatric Institute and Clinic
phone: 412-586-9014
e-mail: prasadkm@upmc.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Konasale Prasad, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00514449     History of Changes
Other Study ID Numbers: 0602032
First Submitted: August 8, 2007
First Posted: August 10, 2007
Results First Submitted: December 2, 2011
Results First Posted: May 9, 2018
Last Update Posted: May 9, 2018