Lamictal TM, Haloperidol Decanoate in Schizophrenia (CMCOBaku)

Central Mental Clinic for Outpatients of Baku City

Status and phase: Terminated; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Lamictal TM; Drug: Haloperidol Decanoate

Study type: Interventional

Funder types: Other

Identifiers

NCT00947375

Nadir

Details and patient eligibility

About

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.

Full 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.

Enrollment: 335 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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335 participants in 2 patient groups

Starch

Experimental group

Description:

In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial.

Treatment:

Drug: Lamictal TM

Drug: Haloperidol Decanoate

Lifestyle councelling

No Intervention group

Description:

May be required to comply with US Public Law 110-85, Section 801