Efficacy of add-on mirtazapine on clinical and neuropsychologic parameters in schizophrenic patients treated with conventional antipsychotics: a double-blind, placebo-controlled trial with an open-label extension phase

Stanley Medical Research Institute (USA)0 sites40 target enrollmentMay 25, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Stanley Medical Research Institute (USA)
Enrollment: 40
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 25, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Stanley Medical Research Institute (USA)

Eligibility Criteria

Inclusion Criteria

•Male or female in\- or out\-patients will be recruited if:
•1\. They are aged 18\-65 years
•2\. Have schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders \- Fourth Edition (DSM\-IV) (APA, 1994\); defined schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated) or schizo\-affective disorder, depressive type
•3\. Receiving one or more conventional antipsychotics at cumulative daily dose of at least 400 mg chlorpromazine equivalents (e.g. haloperidol 12 mg daily) (see Table of Antipsychotic Equivalents), which has remained unchanged (also in terms of dosage) during at least 6 last weeks prior to screening baseline (8 weeks for depot antipsychotics).
•Table of antipsychotic equivalents (Basire, 2000\) oral mg/day: chlorpromazine 100 mg (\= 25\-50 mg intramuscular (IM) or 250 mg rectal), fluphenazine 2 mg, levomeptromazine \- not known, pericyazine 24 mg, perphenazine 8 mg, prochlorperazine 15 mg, promazine 100 mg, thioridazine 100 mg, trifluoperazine 5 mg, benperidol 2 mg, droperidol 4 mg (Short t1/2\) or 3 mg IM/intravenous (IV), haloperidol 3 mg or 1\.5 mg IM/IV for doses up to 150 mg/day, trifluoperidol 2 mg, flupentixol 2 mg, zuclopentixol 25 mg up to 150 mg/day, pimozide 2 mg (Long t1/2\), remoxiprid 75 mg, amisulpride 100 mg, sulpiride 200 mg, loxapine 10 mg depot (mg/week), fluphenazine 5\-10 mg (1\-12\.5 mg), pipothiazine 10 mg (5\-12\.5 mg), haloperidol 15 mg (5\-12\.5 mg), flupentixol 10 mg (8\-20 mg), zuclopentixol 100 mg (40\-100 mg), fluspirilene 2 mg \- not fully established.
•4\. Demonstrating less than optimal clinical outcome i.e. experiencing either positive or negative symptoms (disability due to only general symptoms will be insufficient for inclusion) resulting in the illness of at least moderate severity (i.e. 4, moderately ill, or more on the clinical global impression (CGI), severity item) (Guy, 1970\)
•5\. The clinical condition has remained stable during the last 6 weeks prior to the baseline visit
•6\. The patient has a level of understanding that enables reasonable cooperation with the investigator and the ability to fulfil the neurocognitive tests
•7\. The patient has given written informed consent

Exclusion Criteria

•1\. History of allergy or serious adverse events due to mirtazapine
•2\. Previous lack of response to a trial with mirtazapine in daily doses of 30 mg or more during four or more weeks, added to the patient?s current or earlier conventional antipsychotic medication
•3\. Previous lack of response to another antidepressant with affinity to postsynaptic (5\-hydroxytryptamine) 5HT2 receptors (e.g. mianserine, trazodone, or nefazodone) used in adequate doses during four or more weeks
•4\. Current atypical antipsychotic medication (e.g. clozapine, risperidone, olanzapine, sertindole, quetiapine, zotepine, ziprasidone, etc.)
•5\. History of non\-response to either clozapine or other atypical antipsychotics
•6\. Medical or neurological condition or drug treatment that might put patients at serious risk or bias the assessment of their clinical or mental status (e.g. serious unstable physical illness, epilepsy, organic brain syndrome etc.)
•7\. History of or current bipolar disorder or schizoaffective disorder, bipolar type (patients with schizoaffective disorder, depressive type can participate in the study)
•8\. Substance addiction or abuse within the last three months prior to screening
•9\. Clearly predictable poor compliance
•10\. For females of child\-bearing potential: pregnancy, lactation, or inability or unwillingness to use medically acceptable methods of contraception during the study