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Lamictal TM, Haloperidol Decanoate in Schizophrenia (CMCOBaku)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00947375
Recruitment Status : Terminated (All of the mentioned aim and objectives were achieved before the February 2007)
First Posted : July 28, 2009
Last Update Posted : July 28, 2009
Sponsor:
Information provided by:
Central Mental Clinic for Outpatients of Baku City

Tracking Information
First Submitted Date  ICMJE July 20, 2009
First Posted Date  ICMJE July 28, 2009
Last Update Posted Date July 28, 2009
Study Start Date  ICMJE January 2005
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2009)
Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo. [ Time Frame: 2006 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2009)
lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia [ Time Frame: 2007 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lamictal TM, Haloperidol Decanoate in Schizophrenia
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 27, 2009)
335
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Azerbaijan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00947375
Other Study ID Numbers  ICMJE Nadir
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Chief Physician of Central Mental Clinic for Outpatients of Baku City
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Central Mental Clinic for Outpatients of Baku City
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nadir A Aliyev, PHD, MD Outpatient service
PRS Account Central Mental Clinic for Outpatients of Baku City
Verification Date July 2009

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