SchizophreniaPhase 2VISTANCT02008773
A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia
A Phase 2 study testing Valacyclovir HCI 500 mg tablets in people with Schizophrenia, run by Indiana University at 13 sites in United States.
Trial summary
The primary aim of the study is to determine the efficacy of adjunctive valacyclovir, in comparison to placebo, to improve visual (Brief Visuospatial Memory Test) and working (composite score of the Spatial Span and Letter Number Span tests) memory in individuals who are HSV-1 positive and early in the course of… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Valacyclovir HCI 500 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 13 sitesUnited States
- Study dates
- 26 Mar 2014to 20 Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 40 years of age at study entry.
- Able to give written informed consent.
- DSM IV-TR Diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder as confirmed by Structured Clinical Interview for DSM-IV-TR (SCID)
- Onset of schizophreniform disorder, schizophrenia, or schizoaffective disorder within the past eight years as defined by first medical records documentation of these conditions
- Outpatient or inpatient.
- Clinical stability as defined by:
Show all 11Show fewer
- CGI-S score of less than or equal to 4 (moderately ill) at randomization AND
- Participants must not have experienced an exacerbation of their illness within 4 weeks prior to randomization leading to an intensification of psychiatric care in the opinion of the investigator. Examples of intensification of care include, but are not limited to: inpatient hospitalization, day/partial hospitalization, outpatient crisis management, or psychiatric treatment in an emergency room AND
- Antipsychotic treatment stability for at least 4 weeks prior to randomization (no change in antipsychotic dosing, addition of any new antipsychotic medication, or discontinuing an antipsychotic medication)
- Fluent in English.
- Female participants of childbearing potential must test negative for pregnancy at screening visit and agree to use a single, effective, medically acceptable method of birth control for the duration of the study.
Who cannot join
- Known IQ less than 70 as determined by medical history.
- IV drug use within previous three month prior to study entry.
- Any serious active medical condition that affects brain or cognitive functioning (e.g., epilepsy, serious head injury, brain tumor or other neurological disorder) in the investigator's opinion.
- Known medical history of Human Immunodeficiency Virus (HIV)
- Receipt of valacyclovir or chemically-related medication within 2 weeks prior to randomization.
- History of hypersensitivity to valacyclovir or acyclovir as determined by self-report and medical history.
Show all 19Show fewer
- DSM-IV diagnosis of substance dependence within 3 months of study entry (with the exception of nicotine or caffeine dependence).
- Participants who have participated in a clinical trial with any pharmacological treatment intervention for which they received study-related medication in the 4 weeks prior to screening AND participants currently receiving treatment (within 1 dosing interval plus 4 weeks) with an investigational depot formulation of an antipsychotic medication.
- Females who are pregnant or planning to become pregnant or breastfeeding or planning to do so during the study period.
- Participants with current acute, serious, or unstable medical conditions, including, but not limited to: inadequately controlled diabetes, asthma, COPD, recent cerebrovascular accidents, acute systemic infection or immunologic disease, unstable cardiovascular disorders, malnutrition, or hepatic or renal disease, renal including renal failure, gastroenterologic, respiratory, endocrinologic, neurologic, hematologic including thrombotic thrombocytopenia purpura/hemolytic uremic syndrome, or infectious diseases
- Participants who require concomitant treatment with any other medication other than those allowed as specified in Attachment 2, or with any other medication specifically excluded in Attachment 2.
- Clinically significant electrocardiogram (ECG) abnormality prior to randomization as defined by: participants with a corrected QT interval (Bazett's; QTcB) >450 msec (male) or >470 msec (female) prior to randomization. Repeat ECGs will be conducted at the discretion of the principal investigator or medical designee.
- Test positive for (1) Hepatitis C virus antibody, (2) Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody.
- Participants with moderate to severe renal impairment as defined by creatinine clearance (CrCl) < 60 ml/min (measured by the Cockcroft-Gault equation) at screening.
- Participants with hepatic impairment as defined by liver transaminases or total bilirubin > 3 × upper limit of normal (ULN).
- Participants considered a high risk for suicidal acts - active suicidal ideation as determined by clinical interview OR any suicide attempt in 90 days prior to screening.
- Participants who demonstrate overtly aggressive behavior or who are deemed to pose a homicidal risk in the investigator's opinion.
- Participants currently receiving cognitive remediation therapy at time of study entry
- Participants who have had electroconvulsive therapy (ECT) within 12 months of study entry or who will have ECT at any time during the study.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Maryland Psychiatric Research Center
Baltimore, Maryland, 21228
C.I. Trials, Inc.-Los Angeles County
Bellflower, California, 90706
Prevention and Recovery Center for Early Psychosis
Indianapolis, Indiana, 46202
Indiana University Psychotic Disorders Clinic
Indianapolis, Indiana, 46222
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
University of California, Los Angeles
Los Angeles, California, 90095
Yale University
New Haven, Connecticut, 06519
University of California, Riverside at C.I. Trials, Inc.-Inland Empire
Riverside, California, 92506
Centers for Behavioral Health, LLC
Rockville, Maryland, 20850
C.I. Trials, Inc.-Orange County
Santa Ana, California, 92705
Sheppard Pratt Health System
Towson, Maryland, 21204
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
University of Kansas Medical Center-Witchita
Wichita, Kansas, 67214
About this study
The primary aim of the study is to determine the efficacy of adjunctive valacyclovir, in comparison to placebo, to improve visual (Brief Visuospatial Memory Test) and working (composite score of the Spatial Span and Letter Number Span tests) memory in individuals who are HSV-1 positive and early in the course of schizophrenia.
We hypothesize that individuals who are HSV-1 positive, but not those who are HSV-1 negative, will demonstrate significant valacyclovir efficacy for visual and working memory.
Read the detailed description
One hundred and seventy-five participants (N=70 HSV-1 seropositive and N=105 HSV-1 seronegative) will be randomized 1:1 to receive adjunctive valacyclovir or adjunctive placebo for a 16 week period. The primary outcome that will be assessed is improvement in changes in visual and working memory scores in HSV-1 positive and negative participants over the course of the study. We will also measure the overall cognitive functioning and the severity of psychiatric symptoms over the course of the study and will evaluate the tolerability and safety of valacyclovir treatment in this population. In addition, we will explore the relationship between changes in the levels of inflammatory markers (HSV2, CMV, EBV, CRP, and Toxoplasmosis) and treatment response over the course of the study.
- Conditions
- Schizophrenia
- Being tested
- Valacyclovir HCI 500 mg tablets, placebo
- Keywords
- schizophrenia, schizoaffective, schizophreniform, inflammatory markers, HSV1, cognition, early psychosis, valacyclovir
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valacyclovir HCI 500 mg tabletsDrug
Valacyclovir HCI 500 mg capsules 6/day oral for 16 weeks
placeboDrug
Also called placebo capsules
placebo capsules 6/day oral for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| valacyclovir | Active comparator | 3000mg daily oral 16 weeks Receives: Drug: Valacyclovir HCI 500 mg tablets |
| placebo | Placebo comparator | placebo 6 capsules daily oral 16 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Memory
To determine the efficacy of adjunctive valacyclovir, in comparison to placebo, to improve visual memory (Brief Visuospatial Memory Test) in individuals who are HSV-1 positive and early in the course of schizophrenia. The Brief Visuospatial Memory Test is a subscale of the MATRICS Consensus Cognitive Battery (MCCB) and was used to assess visual memory.
The BVMT consists of three trials in which participants must recall shapes by drawing figures on a blank page after being given the opportunity to memorize the figures for 10 seconds. Each page consists of six figures. Points are awarded based on the accuracy of the drawn figure and by correct placement on the page. A minimum of 0 to 12 points are awarded per trial, so a participant can score between 0 and 36 points for all three trials. The raw score is then converted to a t-score, normed by age and sex. The min and max t-scores are between 0-100, a higher t-score representing a better outcome.
Measured: Baseline, 8 weeks, and 16 weeks
Working Memory
Determine the efficacy of adjunctive valacyclovir, in comparison to placebo, on working memory (composite score of the Wechsler Memory Scale-III: Spatial Span and Letter Number Span tests). WMS has 2 sections in which a subject recalls increasingly difficult sequences. The total raw score range for both sections is 0-32. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance.
LNS consists of 24 increasingly difficult sequences of letters and numbers that a subject is to recall and repeat back in Numeric-Alpha sequential order. The total raw score range is 0-24. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance. The Working Memory composite score is calculated by summing the WMS and LNS tscores, a higher tscore reflects better performance.
Measured: Baseline, 8 weeks, and 16 weeks
Secondary outcomes (4)
Cognitive Performance
To evaluate the efficacy of adjunctive valacyclovir, in comparison to placebo, to improve general cognitive performance as measured by the MATRICS Consensus Cognitive Battery composite score in HSV1 + and - participants. MCCB is comprised of 10 tests, Trail Making Test Part A; Brief Assessment in Cognition in Schizophrenia Symbol Coding; Hopkins Verbal Learning Test-Revised; Wechsler Memory Scale-III Spatial Span; Letter Number Sequencing; Neuropsychological Assessment Battery Mazes; Brief Visuospatial Memory Test-Revised; Category Fluency Animal Naming; Mayer-Salovey-Caruso Emotional Intelligence Test Managing Emotions; and Continuous Performance Test-Identical Pairs. For each test, a score is derived based on the raw item values. Each of the individual item raw scores is standardized to age and gender corrected tscores which are then summed to convert into a composite score ranging from <214->486 based on the MCCB scoring manual, with a higher score reflecting better performance.
Measured: Baseline, 8 Weeks, and 16 weeks
Functional Performance
To evaluate the efficacy of adj. valacyclovir to improve functional performance and quality of life (QOL) as measured by the UCSD Performance-Based Skills Assessment, Version B (UPSA-B); QOL Enjoyment and Satisfaction Questionnaire Short Form (Q-LES); and Personal and Social Performance Scale (PSP). The UPSA-B is a performance-based assessment of improvement in functional capacity.Participants are asked to role-play communication and finance tasks. Scores are assigned for each of the 2 subscales and formula is used to calculate a total score (0-100). A higher score reflects better performance. The Q-LES, 16 item scale yields a raw total score, ranging from 14-70, with a higher score representing higher QOL. The PSP scale is a single item scale assessing 4 domains of functioning: personal\&social relationships, socially useful activities, self-care, and disturbing\&aggressive behaviors. An adjusted score from 0-100 is generated, a higher score reflects better functioning.
Measured: Baseline, 8 weeks, and 16 weeks
Psychosis Symptoms
To evaluate the efficacy of adj. valacyclovir for general and positive symptoms (sxs) as measured by the PANSS total and factor scores and negative sxs as measured by the NSA-16.The PANSS contains 30 items that assess sxs of psychotic d/os.Positive sxs are rated on 7 items, negative sxs on 7 items, and general psych. on 16 items.Scores for each item range from 1-7.Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psych. scores ranging from 16-112.Total scores for all items range from 30-210.Additionally a factor score can be derived for Cognition/Disorganization by using scores from 7 items and ranges from 7-49.For factor and total scores a lower score reflects fewer sxs.The NSA-16 is used to rate behaviors commonly associated with negative sxs of schizophrenia.The scale rates subjects on 16 anchors from 1 to 6.The total score is the sum of the 16 specific items and ranges from 16 to 96; a higher score indicates greater severity of illness.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Functional Performance
To evaluate the efficacy of adjunctive valacyclovir, compared to placebo, to improve to improve global functional assessments as measured by the Clinical Global Impressions Severity Scale (CGI-S). The CGI-S is a single 7-point Likert scale rating severity of psychopathology on a scale of 1 (normal, not ill) to 7 (very severely ill).
Measured: Baseline, 8 weeks, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study start26 Mar 2014
- Primary completion20 Jun 2017
- Study completion20 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute, Sheppard Pratt Health System, University of Maryland, Centers for Behavioral Health, LLC, Laureate Institute for Brain Research, Inc., University of Kansas Medical Center, University of California, Los Angeles, Yale University, Innovative Clinical Research, Inc., University of California Riverside at C.I. Trials, Inc.-Inland Empire, Clinical Innovations
- Responsible party
- Principal investigator, Alan Breier, Indiana University
- Investigators
- Alan Breier, MD, Principal investigator, Indiana UniversityFaith Dickerson, PhD, Principal investigator, Shepard Pratt Health SystemRobert Buchanan, MD, Principal investigator, University of MarylandRobert Litman, MD, Principal investigator, Centers for Behavioral Health, LLCSheldon Preskorn, MD, Principal investigator, University of Kansas (KUMC)Brent Wurfel, MD, PhD, Principal investigator, Laureate Institute for Brain ResearchStephen Marder, MD, Principal investigator, University of California, Los AngelesKeith Nuechterlein, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008773
- Sponsor's protocol ID
- 1310496490
- Acronym
- VISTA
- Status last verified
- Jan 2019
- First submitted
- 7 Dec 2013
- Last updated
- 30 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Breier A, Buchanan RW, D'Souza D, Nuechterlein K, Marder S, Dunn W, Preskorn S, Macaluso M, Wurfel B, Maguire G, Kakar R, Highum D, Hoffmeyer D, Coskinas E, Litman R, Vohs JL, Radnovich A, Francis MM, Metzler E, Visco A, Mehdiyoun N, Yang Z, Zhang Y, Yolken RH, Dickerson FB. Herpes simplex virus 1 infection and valacyclovir treatment in schizophrenia: Results from the VISTA study. Schizophr Res. 2019 Apr;206:291-299. doi: 10.1016/j.schres.2018.11.002. Epub 2018 Nov 23.
PubMed 30478008
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia
- ClinicalTrials.gov ID
- NCT02008773
- Acronym / sponsor ID
- VISTA / 1310496490
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, schizoaffective, schizophreniform, inflammatory markers, HSV1, cognition, early psychosis, valacyclovir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute, Sheppard Pratt Health System, University of Maryland, Centers for Behavioral Health, LLC, Laureate Institute for Brain Research, Inc., University of Kansas Medical Center, University of California, Los Angeles, Yale University, Innovative Clinical Research, Inc., University of California Riverside at C.I. Trials, Inc.-Inland Empire, Clinical Innovations
- Study start
- 26 Mar 2014 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Posted 30 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the study is to determine the efficacy of adjunctive valacyclovir, in comparison to placebo, to improve visual (Brief Visuospatial Memory Test) and working (composite score of the Spatial Span and Letter Number Span tests) memory in individuals who are HSV-1 positive and early in the course of schizophrenia.
We hypothesize that individuals who are HSV-1 positive, but not those who are HSV-1 negative, will demonstrate significant valacyclovir efficacy for visual and working memory.
Detailed description
One hundred and seventy-five participants (N=70 HSV-1 seropositive and N=105 HSV-1 seronegative) will be randomized 1:1 to receive adjunctive valacyclovir or adjunctive placebo for a 16 week period. The primary outcome that will be assessed is improvement in changes in visual and working memory scores in HSV-1 positive and negative participants over the course of the study. We will also measure the overall cognitive functioning and the severity of psychiatric symptoms over the course of the study and will evaluate the tolerability and safety of valacyclovir treatment in this population. In addition, we will explore the relationship between changes in the levels of inflammatory markers (HSV2, CMV, EBV, CRP, and Toxoplasmosis) and treatment response over the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| valacyclovir | Active comparator | Drug: Valacyclovir HCI 500 mg tablets3000mg daily oral 16 weeks |
| placebo | Placebo comparator | Drug: placeboplacebo 6 capsules daily oral 16 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 18 to 40 years of age at study entry.
- Able to give written informed consent.
- DSM IV-TR Diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder as confirmed by Structured Clinical Interview for DSM-IV-TR (SCID)
- Onset of schizophreniform disorder, schizophrenia, or schizoaffective disorder within the past eight years as defined by first medical records documentation of these conditions
- Outpatient or inpatient.
Key exclusion criteria (19 listed)
- Known IQ less than 70 as determined by medical history.
- IV drug use within previous three month prior to study entry.
- Any serious active medical condition that affects brain or cognitive functioning (e.g., epilepsy, serious head injury, brain tumor or other neurological disorder) in the investigator's opinion.
- Known medical history of Human Immunodeficiency Virus (HIV)
- Receipt of valacyclovir or chemically-related medication within 2 weeks prior to randomization.
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 HCI 500 mg tabletsValacyclovir HCI 500 mg capsules 6/day oral for 16 weeks | Drug | valacyclovir |
| placeboAlso: placebo capsulesplacebo capsules 6/day oral for 16 weeks | Drug | placebo |
Primary outcome
Visual Memory
Time frame: Baseline, 8 weeks, and 16 weeks
To determine the efficacy of adjunctive valacyclovir, in comparison to placebo, to improve visual memory (Brief Visuospatial Memory Test) in individuals who are HSV-1 positive and early in the course of schizophrenia. The Brief Visuospatial Memory Test is a subscale of the MATRICS Consensus Cognitive Battery (MCCB) and was used to assess visual memory. The BVMT consists of three trials in which participants must recall shapes by drawing figures on a blank page after being given the opportunity to memorize the figures for 10 seconds. Each page consists of six figures. Points are awarded based on the accuracy of the drawn figure and by correct placement on the page. A minimum of 0 to 12 points are awarded per trial, so a participant can score between 0 and 36 points for all three trials. The raw score is then converted to a t-score, normed by age and sex. The min and max t-scores are between 0-100, a higher t-score representing a better outcome.
Working Memory
Time frame: Baseline, 8 weeks, and 16 weeks
Determine the efficacy of adjunctive valacyclovir, in comparison to placebo, on working memory (composite score of the Wechsler Memory Scale-III: Spatial Span and Letter Number Span tests). WMS has 2 sections in which a subject recalls increasingly difficult sequences. The total raw score range for both sections is 0-32. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance. LNS consists of 24 increasingly difficult sequences of letters and numbers that a subject is to recall and repeat back in Numeric-Alpha sequential order. The total raw score range is 0-24. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance. The Working Memory composite score is calculated by summing the WMS and LNS tscores, a higher tscore reflects better performance.
4 secondary outcomes
Cognitive Performance
Time frame: Baseline, 8 Weeks, and 16 weeks
Functional Performance
Time frame: Baseline, 8 weeks, and 16 weeks
Psychosis Symptoms
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Functional Performance
Time frame: Baseline, 8 weeks, and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30478008Breier A, Buchanan RW, D'Souza D, Nuechterlein K, Marder S, Dunn W, Preskorn S, Macaluso M, Wurfel B, Maguire G, Kakar R, Highum D, Hoffmeyer D, Coskinas E, Litman R, Vohs JL, Radnovich A, Francis MM, Metzler E, Visco A, Mehdiyoun N, Yang Z, Zhang Y, Yolken RH, Dickerson FB. Herpes simplex virus 1 infection and valacyclovir treatment in schizophrenia: Results from the VISTA study. Schizophr Res. 2019 Apr;206:291-299. doi: 10.1016/j.schres.2018.11.002. Epub 2018 Nov 23.
- IU Psychotic Disorders ProgramLink provided by the sponsor.
- Centers for Behavioral Health, LLCLink provided by the sponsor.
- Laureate Institute for Brain ResearchLink provided by the sponsor.
- Kansas University School of Medicine, PsychiatryLink provided by the sponsor.
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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.
Alan Breier, MD principal investigator
Indiana University
Faith Dickerson, PhD principal investigator
Shepard Pratt Health System
Robert Buchanan, MD principal investigator
University of Maryland
13 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 HCI 500 mg tablets in people with Schizophrenia, run by Indiana University at 13 sites in United States.
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 11 inclusion and 19 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Visual Memory (time frame: Baseline, 8 weeks, and 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02008773, which also lists 1 linked publication.
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 30 Jan 2019.