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Lamictal TM, Haloperidol Decanoate in Schizophrenia (CMCOBaku)

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Phase 4
Locations
Azerbaijan
Study Type
Interventional
Intervention
Lamictal TM
Haloperidol Decanoate
Sponsored by
Central Mental Clinic for Outpatients of Baku City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, lamictal TM, haloperidol decanoate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Central Mental Clinic for Outpatients of Baku City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Starch

Lifestyle councelling

Arm Description

In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial.

May be required to comply with US Public Law 110-85, Section 801

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia

Full Information

First Posted
July 20, 2009
Last Updated
July 27, 2009
Sponsor
Central Mental Clinic for Outpatients of Baku City
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1. Study Identification

Unique Protocol Identification Number
NCT00947375
Brief Title
Lamictal TM, Haloperidol Decanoate in Schizophrenia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Why Stopped
All of the mentioned aim and objectives were achieved before the February 2007
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Central Mental Clinic for Outpatients of Baku City

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, lamictal TM, haloperidol decanoate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
335 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Starch
Arm Type
Experimental
Arm Description
In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial.
Arm Title
Lifestyle councelling
Arm Type
No Intervention
Arm Description
May be required to comply with US Public Law 110-85, Section 801
Intervention Type
Drug
Intervention Name(s)
Lamictal TM
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Haloperidol Decanoate
Intervention Description
Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks.
Primary Outcome Measure Information:
Title
Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo.
Time Frame
2006
Secondary Outcome Measure Information:
Title
lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia
Time Frame
2007

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadir A Aliyev, PHD, MD
Organizational Affiliation
Outpatient service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Mental Clinic for Outpatients of Baku City
City
Baku
ZIP/Postal Code
AZ0010
Country
Azerbaijan

12. IPD Sharing Statement

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Lamictal TM, Haloperidol Decanoate in Schizophrenia

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