PsychosisPhase 2NCT00175513
V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis
A Phase 2 study testing Valacyclovir (Valtrex) in people with Psychosis, run by University of British Columbia at 2 sites in Canada.
Trial summary
This is an 18 week (2 weeks run-in, 16 weeks double blind) trial, to determine if an antiviral drug, valacyclovir (Valtrex) is helpful in treating the symptoms of psychosis, a form of a mental disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Valacyclovir (Valtrex)
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2005to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects antipsychotic, mood stabilizing and antidepressant drug treatment must have been stable for at least 3 months, and there is no plan to change the drug treatment during the 4-month phase of the study.
- Subjects must be seropositive for HSV-1, HSV-2 and/or CMV.
- Subjects must achieve a level of understanding and expressive capacity sufficient to communicate adequately with the study coordinator and to participate in cognitive testing.
- Subjects must be able to provide written informed consent.
Who cannot join
- Females of childbearing age will agree not to become pregnant and will agree to use a medically acceptable method of birth control.
- Inability to participate in cognitive testing due to severe persistent psychosis or other condition.
- Mental handicap.
- Subjects with known hypersensitivity or allergy to valacyclovir or acyclovir.
- Patient taking nontopical antiviral medications with anti-herpes activity on a regular basis
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Eric Martin Pavilion
Victoria, British Columbia
Peace Arch Hospital
White Rock, British Columbia
About this study
This is an 18 week (2 weeks run-in, 16 weeks double blind) trial, to determine if an antiviral drug, valacyclovir (Valtrex) is helpful in treating the symptoms of psychosis, a form of a mental disorder.
Read the detailed description
There is evidence that some of the symptoms of psychosis may be related to past infection with common viruses.
Researchers are looking to recruit a total of 100 subjects with evidence in the past, of exposure to at least 1 of 3 viruses. The viruses include herpes type 1 (HSV-1, which causes cold sores of the lip and has affected about 6/10 people in Vancouver), herpes type 2 (HSV-2 which causes genital sores, and has affected less than 1/10 people in Vancouver) and cytomegalovirus (CMV, which causes few symptoms but has affected 8/10 people in Vancouver). People who have been infected with these viruses in the past develop antibodies in the blood. The antibodies can be measured in blood, and are a test of whether or not there was infection in the past, and possibly affecting the symptoms of psychosis.
- Conditions
- Psychosis
- Being tested
- Valacyclovir (Valtrex)
- Keywords
- Psychosis, early psychosis, first episode psychosis, schizophrenia, schizoaffective, schizophreniform, bipolar disorder, valtrex, valacyclovir.
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valacyclovir (Valtrex)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Investigators
- William Honer, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175513
- Sponsor's protocol ID
- C04-0503
- Other IDs
- FHA: 2005-07, TPD: 094295
- Status last verified
- Apr 2011
- First submitted
- 11 Sep 2005
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis
- ClinicalTrials.gov ID
- NCT00175513
- Acronym / sponsor ID
- C04-0503
- Conditions
- Psychosis
- Keywords
- Psychosis, early psychosis, first episode psychosis, schizophrenia, schizoaffective, schizophreniform, bipolar disorder, valtrex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Sep 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an 18 week (2 weeks run-in, 16 weeks double blind) trial, to determine if an antiviral drug, valacyclovir (Valtrex) is helpful in treating the symptoms of psychosis, a form of a mental disorder.
Detailed description
There is evidence that some of the symptoms of psychosis may be related to past infection with common viruses.
Researchers are looking to recruit a total of 100 subjects with evidence in the past, of exposure to at least 1 of 3 viruses. The viruses include herpes type 1 (HSV-1, which causes cold sores of the lip and has affected about 6/10 people in Vancouver), herpes type 2 (HSV-2 which causes genital sores, and has affected less than 1/10 people in Vancouver) and cytomegalovirus (CMV, which causes few symptoms but has affected 8/10 people in Vancouver). People who have been infected with these viruses in the past develop antibodies in the blood. The antibodies can be measured in blood, and are a test of whether or not there was infection in the past, and possibly affecting the symptoms of psychosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects antipsychotic, mood stabilizing and antidepressant drug treatment must have been stable for at least 3 months, and there is no plan to change the drug treatment during the 4-month phase of the study.
- Subjects must be seropositive for HSV-1, HSV-2 and/or CMV.
- Subjects must achieve a level of understanding and expressive capacity sufficient to communicate adequately with the study coordinator and to participate in cognitive testing.
- Subjects must be able to provide written informed consent.
Key exclusion criteria (5 listed)
- Females of childbearing age will agree not to become pregnant and will agree to use a medically acceptable method of birth control.
- Inability to participate in cognitive testing due to severe persistent psychosis or other condition.
- Mental handicap.
- Subjects with known hypersensitivity or allergy to valacyclovir or acyclovir.
- Patient taking nontopical antiviral medications with anti-herpes activity on a regular basis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valacyclovir (Valtrex) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Honer, MD principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valacyclovir (Valtrex) in people with Psychosis, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2011.