Clinical trial NCT00947375: Lamictal TM, Haloperidol Decanoate in Schizophrenia
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: schizophrenia
lamictal TM
haloperidol decanoate
Lead sponsor: Central Mental Clinic for Outpatients of Baku City
Sponsor class: OTHER
First posted: 2009-07-28
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo.
timeFrame: 2006
Secondary outcomes:
measure: lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia
timeFrame: 2007
Other outcomes:
Locations:
city: Baku
country: Azerbaijan
facility: Central Mental Clinic for Outpatients of Baku City
Study officials:
affiliation: Outpatient service
name: Nadir A Aliyev, PHD, MD
role: PRINCIPAL_INVESTIGATOR
References: