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Lamictal TM, Haloperidol Decanoate in Schizophrenia

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00947375
Acronym
CMCOBaku
Enrollment
335
Registered
2009-07-28
Start date
2005-01-31
Completion date
2007-01-31
Last updated
2009-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

schizophrenia, lamictal TM, haloperidol decanoate

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.

Interventions

DRUGLamictal 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.

Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks.

Sponsors

Central Mental Clinic for Outpatients of Baku City
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo.2006

Secondary

MeasureTime frame
lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia2007

Countries

Azerbaijan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026