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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


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.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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