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Lamictal TM, Haloperidol Decanoate in Schizophrenia (CMCOBaku)

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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

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lamictal TM Drug: Haloperidol Decanoate Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 335 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : January 2005
Primary Completion Date : January 2006
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Haloperidol Decanoate
Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks.
No Intervention: Lifestyle councelling
May be required to comply with US Public Law 110-85, Section 801



Primary Outcome Measures :
  1. Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo. [ Time Frame: 2006 ]

Secondary Outcome Measures :
  1. lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia [ Time Frame: 2007 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Chief Physician of Central Mental Clinic for Outpatients of Baku City
ClinicalTrials.gov Identifier: NCT00947375     History of Changes
Other Study ID Numbers: Nadir
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: July 28, 2009
Last Verified: July 2009

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Haloperidol
Haloperidol decanoate
Lamotrigine
Decanoic acid
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Antifungal Agents
Anti-Infective Agents