SchizophreniaPhase 2SEAMSNCT00514449

Systematic Evaluation of Antiviral Medication in Schizophrenia

A Phase 2 study testing Valacyclovir in people with Schizophrenia and Schizoaffective Disorder, run by Konasale Prasad at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder
What is being tested?: Valacyclovir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: 2 sitesUnited States
Study dates: Jun 2007to Sep 2016
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 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Both genders between the ages of 18-50 years
Schizophrenia or schizoaffective disorder as defined in DSM-IV
Duration of illness 10 years or less
On a stable dose of an antipsychotic medication for at least a month
Should score 4 or more on at least one of the subscales of PANSS
Positive for HSV1
Written informed consent

Who cannot join

Substance abuse in the last month/dependence 6 months prior to the study
History of, or current medical/neurological illnesses which affects CNS function e.g., epilepsy, head injury with prolonged loss of consciousness
Pregnancy
History of immune disorders, HIV infection or currently receiving immunosuppressants
Subjects on regular antiviral therapy
History of hypersensitivity to Valacyclovir
Mental retardation as defined in DSM-IV

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Wayne State University
Detroit, Michigan, 48201
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: A Randomized Double-blind Controlled Trial of Valacyclovir Add-on Treatment of HSV Positive Early Course Schizophrenia Patients

Read the detailed description

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.

Conditions: Schizophrenia, Schizoaffective Disorder
Being tested: Valacyclovir, Placebo
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.

ValacyclovirDrug
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
PlaceboDrug
2 pills twice a day x 2 weeks, after 2 weeks 3 pills twice a day x 16 weeks along with antipsychotic

Study groups in NCT00514449
Study group	Role	What they receive
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. Receives: Drug: Valacyclovir
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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: Baseline, Week 18

Secondary outcomes (1)

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.
Measured: Baseline, Week 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Sep 2016

First posted10 Aug 2007 (estimated)
Study startJun 2007
Primary completionSep 2016
Study completionSep 2016

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 (2)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00514449
Sponsor's protocol ID: 0602032
Acronym: SEAMS
Status last verified: May 2018
First submitted: 8 Aug 2007
Last updated: 14 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 17033628
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.
PubMed 22446565

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double-blind Controlled Trial of Valacyclovir Add-on Treatment of HSV Positive Early Course Schizophrenia Patients
ClinicalTrials.gov ID: NCT00514449
Acronym / sponsor ID: SEAMS / 0602032
Conditions: Schizophrenia, Schizoaffective Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Konasale PrasadUniversity, hospital or other
Collaborators: Stanley Medical Research Institute, Wayne State University
Study start: Jun 2007
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 10 Aug 2007 (estimated)
Results: Posted 9 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Valacyclovir	Experimental	Drug: Valacyclovir1 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	Drug: Placebo2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Both genders between the ages of 18-50 years
Schizophrenia or schizoaffective disorder as defined in DSM-IV
Duration of illness 10 years or less
On a stable dose of an antipsychotic medication for at least a month
Should score 4 or more on at least one of the subscales of PANSS

Key exclusion criteria (7 listed)

Substance abuse in the last month/dependence 6 months prior to the study
History of, or current medical/neurological illnesses which affects CNS function e.g., epilepsy, head injury with prolonged loss of consciousness
Pregnancy
History of immune disorders, HIV infection or currently receiving immunosuppressants
Subjects on regular antiviral therapy

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
Valacyclovir1 g PO BID x 2 weeks after 2 weeks it goes up to 1.5 g PO BID x 16 weeks along with antipsychotic	Drug	Valacyclovir
Placebo2 pills twice a day x 2 weeks, after 2 weeks 3 pills twice a day x 16 weeks along with antipsychotic	Drug	Sugar pill

Primary outcome

PANSS Positive and Negative Syndrome Scale for Schizophrenia
Time frame: Baseline, Weeks 2, 4, 6, 10, 14, 18
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.
Cognitive Function Neuropsychological Battery (Gur Battery)
Time frame: Baseline, Week 18
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

1 secondary outcome

Changes in Grey Matter Deficit
Time frame: Baseline, Week 18

Results and safety

Results posted to the registry on 9 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Valacyclovir	12	9
Sugar Pill	12	8

Primary outcome: PANSS Positive and Negative Syndrome Scale for Schizophrenia

Time frame: Baseline, Weeks 2, 4, 6, 10, 14, 18. Mean (Standard Deviation). Unit: Scores on the scale

Measure	Valacyclovir n = 12	Sugar Pill n = 12
Scores at Baseline of the trial	70.08 (12.616)	83.92 (13.895)
Scores at week 2 of the trial	72.25 (11.450)	77 (14.917)
Scores at week 4 of the trial	67.36 (12.314)	75.2 (13.998)
Scores at week 6 of the trial	65.583 (9.228)	74.3 (16.275)
Scores at week 10 of the trial	65.2 (10.737)	73.2 (12.044)
Scores at week 14 of the trial	57.1 (12.511)	69.6 (14.886)
Scores at the end of the trial	56.5 (9.289)	67.125 (13.726)

Population analysed: Comparative analysis of active drug versus placebo

Primary outcome: Cognitive Function Neuropsychological Battery (Gur Battery)

Time frame: Baseline, Week 18. Mean (Standard Deviation). Unit: units on a scale

Measure	Valacyclovir n = 12	Sugar Pill n = 12
Working Memory: 2-Back Test Accuracy	2.13 (2.68)	0.13 (2.9)
Immediate Verbal Memory Reaction Accuracy	2.44 (2.62)	-0.49 (3.11)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2, 4, 6, 10, 14, and 18 weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Valacyclovir	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
Sugar Pill	0 of 12 (0%)	6 of 12 (50%)	Not reported

Limitations and caveats (from the sponsor): This was a small sample study designed as a proof of concept. A larger study will follow.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17033628Prasad 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.
Derived from this study: PubMed 22446565Prasad 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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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.

Konasale Prasad, MD principal investigator

Western Psychiatric Institute and Clinic

Vishwajit Nimgaonkar, MD, PhD principal investigator

Western Psychiatric Institute and Clinic

Matcheri Keshavan, MD principal investigator

Wayne State University

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 in people with Schizophrenia and Schizoaffective Disorder, run by Konasale Prasad at 2 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 7 inclusion and 7 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 Jun 2018. 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 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 9 May 2018). 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?

PANSS Positive and Negative Syndrome Scale for Schizophrenia (time frame: Baseline, Weeks 2, 4, 6, 10, 14, 18). 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 NCT00514449, which also lists 2 linked publications.

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 Jun 2018.