Lamictal TM, Haloperidol Decanoate in Schizophrenia

Phase 4

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Lamictal TM; Drug: Haloperidol Decanoate

• Registration Number: NCT00947375
• Lead Sponsor: Central Mental Clinic for Outpatients of Baku City

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2006-01
• Study Completion: 2007-01
• Status Verified: 2009-07
• Study First Submitted: 2009-07-20
• Study First Submitted QC: 2009-07-27
• Last Update Submitted: 2009-07-27
• Study First Posted: 2009-07-28
• Last Update Posted: 2009-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

• age from 18-60;
• both gender;
• resistant scizophrenia patients;
• previous treatment history;
• verbal resistant hallucinosis.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Starch	Lamictal TM	In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial.
Starch	Haloperidol Decanoate	In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial.

Primary Outcome Measures

Name	Time	Method
Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo.	2006

Secondary Outcome Measures

Name	Time	Method
lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia	2007

Trial Locations

Locations (1)

Central Mental Clinic for Outpatients of Baku City; 🇦🇿 Baku, Azerbaijan