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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Lamictal TM
Drug: Haloperidol Decanoate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Central Mental Clinic for Outpatients of Baku City:

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

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

Enrollment: 335
Study Start Date: January 2005
Study Completion Date: January 2007
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Starch
In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial.
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
No Intervention: Lifestyle councelling
May be required to comply with US Public Law 110-85, Section 801

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947375

Locations
Azerbaijan
Central Mental Clinic for Outpatients of Baku City
Baku, Azerbaijan, AZ0010
Sponsors and Collaborators
Central Mental Clinic for Outpatients of Baku City
Investigators
Principal Investigator: Nadir A Aliyev, PHD, MD Outpatient service
  More Information

No publications provided

Responsible Party: Chief Physician of Central Mental Clinic for Outpatients of Baku City, Chief Physician of Central Mental Clinic for Outpatients of Baku City
ClinicalTrials.gov Identifier: NCT00947375     History of Changes
Other Study ID Numbers: Nadir
Study First Received: July 20, 2009
Last Updated: July 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Central Mental Clinic for Outpatients of Baku City:
schizophrenia
lamictal TM
haloperidol decanoate

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Haloperidol
Haloperidol decanoate
Lamotrigine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents
Anticonvulsants

ClinicalTrials.gov processed this record on July 22, 2014