Lamictal TM, Haloperidol Decanoate in Schizophrenia

NCT00947375 | Terminated Phase 4 DMC

• 1 other identifier: Nadir
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

schizophrenia; lamictal TM; haloperidol decanoate

Outcome Measures

Primary Outcomes (1)

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

  2006

Secondary Outcomes (1)

• lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia

  2007

Study Arms (2)

Starch

EXPERIMENTAL

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

Drug: Lamictal TM; Drug: Haloperidol Decanoate

Lifestyle councelling

NO INTERVENTION

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

Interventions

Lamictal TM DRUG

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.

Starch

Haloperidol Decanoate DRUG

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

Starch

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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).
• age from 18-60;
• both gender;
• resistant scizophrenia patients;
• previous treatment history;
• verbal resistant hallucinosis.

Sponsors & Collaborators

• Central Mental Clinic for Outpatients of Baku City: lead

Study Sites (1)

Central Mental Clinic for Outpatients of Baku City

Baku, AZ0010, Azerbaijan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

haloperidol decanoate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Nadir A Aliyev, PHD, MD

  Outpatient service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 28, 2009
• Study Start: January 1, 2005
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2007
• Last Updated: July 28, 2009

Record last verified: 2009-07

Locations

AZ (1)