Title
Lamictal TM, Haloperidol Decanoate in Schizophrenia
The Effect of Lamictal TM Augmentation of Haloperidol Decanoate in the Treatment of Resistant Schizophrenia Predominantly by Verbal Resistant Hallucinosis: Randomized, Double-blind, Placebo-controlled, Study
Phase
Phase 4Lead Sponsor
Central Mental Clinic for Outpatients of Baku CityStudy Type
InterventionalStatus
TerminatedIndication/Condition
SchizophreniaIntervention/Treatment
lamotrigine haloperidol ...Study Participants
335The purpose of this study is to determine the effect of lamotrigine augmentation of Haloperidol decanoate in the treatment of Resistant Schizophrenia predominantly by verbal resistant hallucinosis: A randomized, double-blind, placebo-controlled, study.
Nadir A.Aliyev & Zafar N.Aliyev
Central Mental Clinic for Outpatients of Baku city of Azerbaijan Republic
Abstract:
OBJECTIVE: The current paper reports on a double-blind, randomized study of the role of lamotrigine as an augmentation agent to haloperidol decanoate in the treatment of out patient's schizophrenia with verbal resistant hallucinosis.
METHOD:A structured clinical interview, for DSM-IV Axis I Disorder, Patient Edition, was used to diagnose schizophrenia according to DSM-IV. Three hundred fifty patients were studied. The patients were then randomly divided into two groups on 175 subjects in each group. First group patients received either haloperidol deaconate 50 mg in weekly intramuscular and lamotrigine 150-200 mg in day per so for 12 weeks. Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks. Data for clinical assessments were collected at weeks 0, 6 and 12 weeks. The expressiveness of psychopathology was estimated on PANSS. Test response in both groups was defined as a reduction in the PANSS by using analysis of variance and chi-square tests.
First group patients received either haloperidol deaconate 50 mg in weekly intramuscular and Lamictal TM 150-200 mg in day per so for 12 weeks.
Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks.
In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial.
May be required to comply with US Public Law 110-85, Section 801
Exclusion Criteria: Display an acute systemic medical disorder or a medical disorder requiring frequent changes in medication; Display a history of seizures, cerebrovascular disease, structural brain damage, from trauma, focal neurological sings on examination, or evidence of any progressive neurological disorder, substance dependence (except tobacco). Inclusion Criteria: age from 18-60; both gender; resistant scizophrenia patients; previous treatment history; verbal resistant hallucinosis.