ISRCTN77257074
Terminated
Phase 3
AnTiconvuLsant AugmeNtation Trial In Schizophrenia: a randomised, pragmatic double-blind, placebo-controlled trial to assess the effectiveness of valproate augmentation of antipsychotic treatment in patients with residual psychotic symptoms
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- King's College London
- Enrollment
- 371
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 04/05/2021:
- •1\. Aged 18 and above at the time of consent
- •2\. Adequate command of English to understand the information leaflet
- •3\. Capacity to consent to participation in the study
- •4\. Confirmation of DSM\-5 diagnosis of schizophrenia or schizoaffective disorder using SCID\-5
- •5\. PANSS total symptom severity score \> 70
- •6\. At least one PANSS psychotic item rating of at least moderate severity (\> 3 on one or more psychotic item rating in PANSS)
- •7\. Received treatment with at least one non\-clozapine antipsychotic drug at adequate dose (as defined by Maudsley guidelines)for a duration of at least 6 weeks and in case of a depot be stable for at least 2 treatment cycles or at least 30 days
- •8\. On a stable dose of antipsychotic treatment for at least 2 weeks in case of oral dosage forms
- •9\. Good adherence to antipsychotic treatments as determined by a score \> 4 on the Medication Adherence rating scale
Exclusion Criteria
- •1\. Subject having a rating of 4 or above on the clinical frailty scale
- •2\. Female subject who is pregnant or breast\-feeding
- •3\. Subject with a known history of urea cyclic disorder
- •4\. Subject with a known history of porphyria
- •5\. Subject with a known history of severe renal insufficiency
- •6\. Subject with a known history of a mitochondrial disorder and in the opinion of the recruiting researcher will impair the safety of the subject and/or the scientific integrity of the study
- •7\. Subject with carnitine palmitoyltransferase (CPT) type II deficiency
- •8\. Subject currently taking clozapine
- •9\. Subject currently taking valproate
- •10\. Subject who had stopped taking valproate in the past six weeks prior to screening due to adverse effects
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
egative symptom treatment in schizophrenia disorderSchizophrenia disorder.paranoid schizophrenia, hebephrenic schizophrenia, catatonic schizophrenia ,undiffrentiated schizophreniaIRCT138902113843N1Ahvaz Jundishapur University of Medical Sciences40
Completed
Not Applicable
The Effect of Sertraline In Treatment Of SchizophreniaIRCT2014041317246N1Vice Chancellor for Research and Technology Development-Ahwaz Jondishapur University of Medical Sci30
Completed
Not Applicable
Pilot study for a new treatment of schizophrenia: a double-blind crossover transcranial magnetic stimulatioISRCTN93378085Record Provided by the NHSTCT Register - 2007 Update - Department of Health12
Recruiting
Phase 2
Evaluation the effect of atypical antipsychotic augmentation with AtomoxetineSchizophrenia.SchizophreniaIRCT20100520003979N9Ahvaz University of Medical Sciences60
Not yet recruiting
Not Applicable
Clonidine: een veelbelovende toevoeging aan de huidige behandeling van schizofrenie.Therapy resistant schizophreniaClonidineNoradrenalineNL-OMON20882niversitair Medisch Centrum Utrecht75