Lamictal TM, Haloperidol Decanoate in Schizophrenia

Study Overview
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Brief Summary
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The 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.

Detailed Description
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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.

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Lamictal TM
* Drug: Haloperidol Decanoate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Starch<br>In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial. | Drug: Lamictal TM<br>* 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.<br>Drug: Haloperidol Decanoate<br>* Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks.<br>|
| No Intervention: Lifestyle councelling<br>May be required to comply with US Public Law 110-85, Section 801 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo. |  | 2006 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia |  | 2007 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, lamictal TM, haloperidol decanoate