E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Schizophrenia, bipolar disorder |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study whether 16 weeks' add-on treatment with anti-viral medicine (valacyclovir), compared to placebo, reduces psychosis symptoms (at week 18) in patients with schizophrenia or bipolar disorder who previously have had a herpes 1-, herpes 2- and/or cytomegalo-virus infection. |
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E.2.2 | Secondary objectives of the trial |
Whether this anti-viral add-on treatment (1) reduces neurological deviations, (2) improves cognitive performance and the total illness picture (including functioning in everyday life), and (3) reduces signs of retroviral activity in the blood (at week 18).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The patient: (a) has schizophrenia (DSM-IV diagnostic code 295) or bipolar illness (DSM-IV 296.0x, 296.40/x, 296.5x, 296.6x, 296.7, 296.89), (b) is 18-55 years old at inclusion, (c) has a psychosis and treatment that are in a stabile phase (maximum 25% variation in neuroleptic dose during the last 3 months prior to inclusion in the study), (d) has a PANSS (Positive And Negative Symptom Scale) [20] total score of at least 50 at inclusion, (e) is sero-positive (IgG) for herpes simplex-virus type 1 (HSV1), herpes simplex-virus type 2 (HSV2) and/or cytomegalo-virus (CMV).
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E.4 | Principal exclusion criteria |
The patient has: (g) psychosis resulting from substance abuse or somatic illness, (h) mental handicap or the inability to complete neuropsychological testing, (i) known over-sensitivity or allergy to (val)acyclovir, (j) immune deficiency illness/HIV/AIDS, (k) on-going active herpes infection (temporary exclusion), (l) another somatic condition that implies risk for a negative somatic effect of valacyclovir, (m) on-going pregnancy or risk for pregnancy (in female patients), (n) notable psychosis symptom improvement (i.e. >20% lower PANSS total score) during the 2 week run-in period with placebo.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in total PANSS-points (Positive and Negative Symptom Scale [20]) from week 0 to week 18 (the measurements at weeks 2, 4, 6, 10 & 14 are ’control stations’ for charting the effect course). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |