To Rescue Cognition With Valaciclovir

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a one-week, randomized, double blind add-on study of valaciclovir versus placebo in 24 clinical patients with Schizophrenia according to DSM IV, currently experiencing psychosis as is defined by the positive items of the Positive and Negative Syndrome Scale (PANNS) score, being five or higher on one item or four on two items of this scale. Each patient will be randomized to double blind treatment with either valaciclovir or placebo for one week.

The main objective is to find a pre- and post-valaciclovir treatment difference in hippocampal inflammation, as measured with positron emission tomography. The secondary objective is to improve cognition by the supposed anti-inflammatory effect on the hippocampus of valaciclovir. This is measured by pre- and post-treatment performance on the PANSS, the attention and memory test.

Both the treatment team and the patient will remain blinded during the course of the study. Following the active treatment phase, patients will receive treatment as clinically indicated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Stanley Medical Research Institute
• Treatments: Acyclovir; Valacyclovir

Criteria

Inclusion Criteria:

• Age above 18

• Written informed consent for participation

• Diagnosis: schizophrenia, all subtypes (DSM-IV 295.xx)

• Psychosis, characterised by a total score on the positive scale on the PANSS above 14. In addition, a minimal score of 4 or more on an item of the positive scale.

Exclusion Criteria:

• The use of benzodiazepines. Benzodiazepines have affinity for the peripheral benzodiazepine receptor which is the target receptor for [11C]-PK11195 PET and they can thus interfere with the PET study.

• The use of a nonsteroidal antiinflammatory drug or paracetamol in week before the PET scans and during the treatment of valaciclovir

• The use of anticoagulants or having coagulation disorder

• Use of somatic medication which may affect the immune system (e.g. corticoids, anti-inflammatory drugs, immune suppressive drugs)

• Use of any investigational drug

• Current or recent (<1 year) alcohol or substance abuse

• Disturbed kidney function

• Disturbed liver function

• Current or recent (<4 weeks) infectious or inflammatory disease

• Current systemic disease

• Major metabolic disease (diabetes, hyper- or hypothyroidism, Cushing disease or Addison disease)

• Somatic, organic or neurological disorder

• Participation in a scientific research study (<1 year) involving radiation

• Claustrophobia

• Presence of materials in the body that can be magnetized, like:

• A pacemaker

• Metal fragments

• Shunts

• Artificial heart valves

• Vascular clips

• Fixed hearing aid

• Tattoos containing metal

• Hair implants

• Artificial dentures