Lamictal TM, Haloperidol Decanoate in Schizophrenia

Schizophrenia Clinical Trial

— CMCOBaku  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00947375
• Other study ID #: Nadir
• Status: Terminated
• Phase: Phase 4
• First received: July 20, 2009
• Last updated: July 27, 2009
• Start date: January 2005
• Est. completion date: January 2007

Study information

• Verified date: July 2009
• Source: Central Mental Clinic for Outpatients of Baku City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 335
• Est. completion date: January 2007
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Azerbaijan	Central Mental Clinic for Outpatients of Baku City	Baku

Sponsors (1)

Lead Sponsor	Collaborator
Central Mental Clinic for Outpatients of Baku City

Country where clinical trial is conducted

Azerbaijan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo.		2006
Secondary	lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia		2007