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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
| Wayne State University | OTHER |
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The purpose of this study is to examine whether antiviral medication will help improve psychotic symptoms and cognition in individuals early in the course of schizophrenia or schizoaffective disorder who are exposed to herpes simplex virus, type 1 (HSV 1), a virus that causes commonly occurring and recurrent cold sores.
The main objective of the study is to evaluate the efficacy of add-on treatment of Valacyclovir (VAV), an antiviral medication, in the treatment of early course schizophrenia/schizoaffective disorder patients. Our main hypothesis is that the VAV add-on treatment will improve positive, negative and cognitive symptoms in herpes simplex virus (HSV) positive schizophrenia or schizoaffective disorder patients. We hypothesize that the grey matter reductions in specific brain regions (such as prefrontal regions) will improve in patients on VAV + antipsychotic compared to those on placebo + antipsychotic and the improvements in positive, negative and cognitive symptoms will be correlated with the grey matter changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valacyclovir | Experimental | 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 | Placebo Comparator | 2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valacyclovir | Drug | 1 g PO BID x 2 weeks after 2 weeks it goes up to 1.5 g PO BID x 16 weeks along with antipsychotic |
|
| Measure | Description | Time Frame |
|---|---|---|
| PANSS Positive and Negative Syndrome Scale for Schizophrenia | This is a structured measure of severity of psychopathology that includes both positive and negative symptoms. The range is a minimum score of 30 and the maximum is 210. The lower scores suggest milder severity of illness domains. | Baseline, Weeks 2, 4, 6, 10, 14, 18 |
| Cognitive Function Neuropsychological Battery (Gur Battery) | All results are given as the mean difference between an 18 week follow-up and the baseline battery administrations.This is a computerized test that measures both accuracy and response times. A range for response times is not available because of individual variabilities. Accuracy scores can vary for each test: Working memory accuracy range was 0-16. Verbal memory accuracy range was 0-20. For both, the higher the score the better. No cut offs are available | Baseline, Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Grey Matter Deficit | Gray matter volume changes (in cc) were measured using structural MRI. Changes were reported as gray matter volume in cc. Note: Assessment of blood oxygenation level dependent (BOLD) changes using fMRI were erroneously included in the original study record. | Baseline, Week 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konasale Prasad, MD | Western Psychiatric Institute and Clinic | Principal Investigator |
| Vishwajit Nimgaonkar, MD, PhD | Western Psychiatric Institute and Clinic | Principal Investigator |
| Matcheri Keshavan, MD | Wayne State University | Principal Investigator |
| Rajaprabhakaran Rajarethinam, MD | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University | Detroit | Michigan | 48201 | United States | ||
| Western Psychiatric Institute and Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17033628 | Background | Prasad KM, Shirts BH, Yolken RH, Keshavan MS, Nimgaonkar VL. Brain morphological changes associated with exposure to HSV1 in first-episode schizophrenia. Mol Psychiatry. 2007 Jan;12(1):105-13, 1. doi: 10.1038/sj.mp.4001915. Epub 2006 Oct 10. | |
| 22446565 | Derived | Prasad KM, Eack SM, Keshavan MS, Yolken RH, Iyengar S, Nimgaonkar VL. Antiherpes virus-specific treatment and cognition in schizophrenia: a test-of-concept randomized double-blind placebo-controlled trial. Schizophr Bull. 2013 Jul;39(4):857-66. doi: 10.1093/schbul/sbs040. Epub 2012 Mar 23. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Sugar Pill | 2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Sugar Pill | 2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PANSS Positive and Negative Syndrome Scale for Schizophrenia | This is a structured measure of severity of psychopathology that includes both positive and negative symptoms. The range is a minimum score of 30 and the maximum is 210. The lower scores suggest milder severity of illness domains. | Comparative analysis of active drug versus placebo | Posted | Mean | Standard Deviation | Scores on the scale | Baseline, Weeks 2, 4, 6, 10, 14, 18 |
|
2, 4, 6, 10, 14, and 18 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach Bloating | Gastrointestinal disorders | Non-systematic Assessment |
This was a small sample study designed as a proof of concept. A larger study will follow.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Konasale Prasad | Western Psychiatric Institute and Clinic | 412-586-9014 | prasadkm@upmc.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077483 | Valacyclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 |
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| Placebo | Drug | 2 pills twice a day x 2 weeks, after 2 weeks 3 pills twice a day x 16 weeks along with antipsychotic |
|
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Cognitive Function Neuropsychological Battery (Gur Battery) | All results are given as the mean difference between an 18 week follow-up and the baseline battery administrations.This is a computerized test that measures both accuracy and response times. A range for response times is not available because of individual variabilities. Accuracy scores can vary for each test: Working memory accuracy range was 0-16. Verbal memory accuracy range was 0-20. For both, the higher the score the better. No cut offs are available | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 18 |
|
|
|
| Secondary | Changes in Grey Matter Deficit | Gray matter volume changes (in cc) were measured using structural MRI. Changes were reported as gray matter volume in cc. Note: Assessment of blood oxygenation level dependent (BOLD) changes using fMRI were erroneously included in the original study record. | Analysis included on all participants on whom baseline and week 18 data were collected. Valacyclovir and placebo groups | Posted | Mean | Standard Deviation | cm^3 | Baseline, Week 18 |
|
|
|
|
| 0 |
| 12 |
| 5 |
| 12 |
| EG001 | Sugar Pill | 2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks. | 0 | 12 | 6 | 12 |
| Fatigue | General disorders | Non-systematic Assessment |
|
| Mild Extrapyramidal Symptoms | Psychiatric disorders | Non-systematic Assessment |
|
| Pain in Elbow when Extended | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Increased Sexual Drive | Psychiatric disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Leg Cramps | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Stomach Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Motion Sickness | Nervous system disorders | Non-systematic Assessment |
|
| Tongue Twitch | Nervous system disorders | Non-systematic Assessment |
|
| Slight Tremor | Nervous system disorders | Non-systematic Assessment |
|
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| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |