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Lamictal TM, Haloperidol Decanoate in Schizophrenia (CMCOBaku)

This study has been terminated.
(All of the mentioned aim and objectives were achieved before the February 2007)
Sponsor:
Information provided by:
Central Mental Clinic for Outpatients of Baku City
ClinicalTrials.gov Identifier:
NCT00947375
First received: July 20, 2009
Last updated: July 27, 2009
Last verified: July 2009

July 20, 2009
July 27, 2009
January 2005
January 2006   (final data collection date for primary outcome measure)
Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo. [ Time Frame: 2006 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00947375 on ClinicalTrials.gov Archive Site
lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia [ Time Frame: 2007 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • 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.
    Other Name: Lamictal TM
  • Drug: Haloperidol Decanoate
    Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks.
    Other Name: Haloperidol Decanoate
  • Experimental: Starch
    In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial.
    Interventions:
    • Drug: Lamictal TM
    • Drug: Haloperidol Decanoate
  • No Intervention: Lifestyle councelling
    May be required to comply with US Public Law 110-85, Section 801
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
335
January 2007
January 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Azerbaijan
 
NCT00947375
Nadir
Yes
Chief Physician of Central Mental Clinic for Outpatients of Baku City, Chief Physician of Central Mental Clinic for Outpatients of Baku City
Central Mental Clinic for Outpatients of Baku City
Not Provided
Principal Investigator: Nadir A Aliyev, PHD, MD Outpatient service
Central Mental Clinic for Outpatients of Baku City
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP