Trial · NCT02008773

A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia

NCT02008773, Phase 2, Completed, Indiana University; results first posted 2019-01-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia. Trials, record NCT02008773. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02008773

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia
NCT number: NCT02008773
Status: Completed
Phases: Phase 2
Enrollment: 170 participants, actual
Lead sponsor: Indiana University
Conditions: Schizophrenia
Interventions: Valacyclovir HCI 500 mg tablets, placebo
First posted: 2013-12-11
Last updated: 2019-01-30
Results first posted: 2019-01-30

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Visual Memory	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.
Primary	Working Memory	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.
Secondary	Cognitive Performance	Baseline, 8 Weeks, and 16 weeks	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.
Secondary	Functional Performance	Baseline, 8 weeks, and 16 weeks	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.
Secondary	Psychosis Symptoms	Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks	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.
Secondary	Functional Performance	Baseline, 8 weeks, and 16 weeks	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).

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Visual Memory	Baseline, 8 weeks, and 16 weeks	visual memory scores	LEAST_SQUARES_MEAN
PRIMARY	Working Memory	Baseline, 8 weeks, and 16 weeks	Working Memory Scores	LEAST_SQUARES_MEAN
SECONDARY	Cognitive Performance	Baseline, 8 Weeks, and 16 weeks	MATRICS Composite Scores	LEAST_SQUARES_MEAN
SECONDARY	Functional Performance	Baseline, 8 weeks, and 16 weeks	Scores on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Psychosis Symptoms	Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks	Symptom Scale Scores	LEAST_SQUARES_MEAN
SECONDARY	Functional Performance	Baseline, 8 weeks, and 16 weeks	scores on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group192

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Visual Memory	HSV1+ Valacyclovir	MATRICS Brief Visuospatial Memory Baseline	37.1	Standard Error 2.1	visual memory scores
Visual Memory	HSV1+ Placebo	MATRICS Brief Visuospatial Memory Baseline	33.9	Standard Error 1.9	visual memory scores
Visual Memory	HSV1- Valacyclovir	MATRICS Brief Visuospatial Memory Baseline	39.6	Standard Error 1.7	visual memory scores
Visual Memory	HSV1- Placebo	MATRICS Brief Visuospatial Memory Baseline	34.2	Standard Error 1.9	visual memory scores
Visual Memory	HSV1+ Valacyclovir	MATRICS Brief Visuospatial Memory Week 8	38.2	Standard Error 2.1	visual memory scores
Visual Memory	HSV1+ Placebo	MATRICS Brief Visuospatial Memory Week 8	34.6	Standard Error 1.9	visual memory scores
Visual Memory	HSV1- Valacyclovir	MATRICS Brief Visuospatial Memory Week 8	39.4	Standard Error 1.7	visual memory scores
Visual Memory	HSV1- Placebo	MATRICS Brief Visuospatial Memory Week 8	38.0	Standard Error 1.9	visual memory scores
Visual Memory	HSV1+ Valacyclovir	MATRICS Brief Visuospatial Memory Week 16	39.6	Standard Error 2.1	visual memory scores
Visual Memory	HSV1+ Placebo	MATRICS Brief Visuospatial Memory Week 16	37.3	Standard Error 1.9	visual memory scores

1 to 10 of 192Source ClinicalTrials.gov

See all 192 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	HSV1+ Placebo	40
Overall Study	STARTED	HSV1+ Valacyclovir	34
Overall Study	STARTED	HSV1- Placebo	46
Overall Study	STARTED	HSV1- Valacyclovir	50
Overall Study	COMPLETED	HSV1+ Placebo	27
Overall Study	COMPLETED	HSV1+ Valacyclovir	25
Overall Study	COMPLETED	HSV1- Placebo	32
Overall Study	COMPLETED	HSV1- Valacyclovir	38
Overall Study	NOT COMPLETED	HSV1+ Placebo	13
Overall Study	NOT COMPLETED	HSV1+ Valacyclovir	9

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Valacyclovir	5	84	5
other	Nausea	Gastrointestinal disorders	Placebo	0	86	0
serious	Psychotic Illness Exacerbation	Psychiatric disorders	Valacyclovir	3	84	3
serious	Psychotic Illness Exacerbation	Psychiatric disorders	Placebo	4	86	7
serious	Diabetic Ketoacidosis	Endocrine disorders	Valacyclovir	1	84	1
serious	Diabetic Ketoacidosis	Endocrine disorders	Placebo	0	86	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Valacyclovir	0	84
Total, all-cause mortality	Placebo	0	86
Total, other adverse events	Valacyclovir	5	84
Total, other adverse events	Placebo	0	86
Total, serious adverse events	Valacyclovir	3	84
Total, serious adverse events	Placebo	4	86

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30478008	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Valacyclovir vs Placebo: deaths from any cause	Trial comparisons
Valacyclovir vs Placebo: serious adverse events	Trial comparisons

Tests5

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Category Fluency	Secondary outcome	ConductCognition
Continuous Performance Test	Secondary outcome	ConductCognition
Letter-Number Sequencing Task	Secondary outcome	ConductCognition
Trail Making Test A	Secondary outcome	ConductCognition
Verbal Learning	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02008773

GET https://conductscience.org/api/trials/v1/NCT02008773/results?page=2

API reference For AI assistants