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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 20, 2009

Last Updated Date

July 27, 2009

Start Date ^ICMJE

January 2005

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo. [ Time Frame: 2006 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00947375 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia [ Time Frame: 2007 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

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

Study Arm (s)

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

Enrollment ^ICMJE

335

Completion Date

January 2007

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Azerbaijan

Administrative Information

NCT Number ^ICMJE

NCT00947375

Other Study ID Numbers ^ICMJE

Nadir

Has Data Monitoring Committee

Yes

Responsible Party

Chief Physician of Central Mental Clinic for Outpatients of Baku City, Chief Physician of Central Mental Clinic for Outpatients of Baku City

Study Sponsor ^ICMJE

Central Mental Clinic for Outpatients of Baku City

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Nadir A Aliyev, PHD, MD

Outpatient service

Information Provided By

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

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