Lamictal TM, Haloperidol Decanoate in Schizophrenia
Information source: Central Mental Clinic for Outpatients of Baku City
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Lamictal TM (Drug); Haloperidol Decanoate (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Central Mental Clinic for Outpatients of Baku City Official(s) and/or principal investigator(s): Nadir A Aliyev, PHD, MD, Principal Investigator, Affiliation: Outpatient service
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo.
Secondary outcome: lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia
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
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Central Mental Clinic for Outpatients of Baku City, Baku AZ0010, Azerbaijan
Additional Information
Starting date: January 2005
Last updated: July 27, 2009
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