We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Research Study of Bipolar Mood Symptoms and Cognitive Problems

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00428298
First Posted: January 30, 2007
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: September 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Drug: Valacyclovir
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Active Treatment Valacyclovir Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
Placebo Treatment Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.

Participant Flow:   Overall Study
    Active Treatment Valacyclovir   Placebo Treatment
STARTED   30   30 
Second RBANS at Study Exit   3   3 
COMPLETED   16   19 
NOT COMPLETED   14   11 



  Baseline Characteristics
  Hide 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
Active Treatment Valacyclovir Valacyclovir: Subjects take two 500 mg capsules twice daily for 16 weeks.
Placebo Treatment Placebo: Subjects take two 500 mg capsules twice daily for 16 weeks.
Total Total of all reporting groups

Baseline Measures
   Active Treatment Valacyclovir   Placebo Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      30 100.0%      30 100.0%      60 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 45  (7)   41  (10)   42  (8.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      19  63.3%      19  63.3%      38  63.3% 
Male      11  36.7%      11  36.7%      22  36.7% 
Region of Enrollment 
[Units: Participants]
     
United States   30   30   60 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status at 16 Weeks   [ Time Frame: 16 weeks ]

2.  Secondary:   Change From Baseline in Montgomery Asberg Depression Score at 16 Weeks   [ Time Frame: 16 weeks ]

3.  Other Pre-specified:   Change From Baseline in Young Mania Rating Scale (YMRS) at 16 Weeks   [ Time Frame: 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jennifer L. Payne MD
Organization: Johns Hopkins UNiversity School of Medicine
phone: 410-502-0050
e-mail: jpayne5@jhmi.edu


Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00428298     History of Changes
Other Study ID Numbers: 00009034
First Submitted: January 29, 2007
First Posted: January 30, 2007
Results First Submitted: September 20, 2016
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017