Lamictal TM, Haloperidol Decanoate in Schizophrenia

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: January 2006

Detailed Description

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.

Interventions

  • Drug: Lamictal TM
    • 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.
  • Drug: Haloperidol Decanoate
    • Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks.

Arms, Groups and Cohorts

  • Experimental: Starch
    • In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial.
  • No Intervention: Lifestyle councelling
    • May be required to comply with US Public Law 110-85, Section 801

Clinical Trial Outcome Measures

Primary Measures

  • Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo.
    • Time Frame: 2006

Secondary Measures

  • lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia
    • Time Frame: 2007

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central Mental Clinic for Outpatients of Baku City
  • Provider of Information About this Clinical Study
    • Chief Physician of Central Mental Clinic for Outpatients of Baku City, Chief Physician of Central Mental Clinic for Outpatients of Baku City
  • Overall Official(s)
    • Nadir A Aliyev, PHD, MD, Principal Investigator, Outpatient service

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