Lamictal TM, Haloperidol Decanoate in Schizophrenia (CMCOBaku)
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|ClinicalTrials.gov Identifier: NCT00947375|
Recruitment Status : Terminated (All of the mentioned aim and objectives were achieved before the February 2007)
First Posted : July 28, 2009
Last Update Posted : July 28, 2009
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
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Lamictal TM Drug: Haloperidol Decanoate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||335 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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 Start Date :||January 2005|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2007|
In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial.
Drug: Lamictal 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.
Drug: Haloperidol Decanoate
Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks.
No Intervention: Lifestyle councelling
May be required to comply with US Public Law 110-85, Section 801
- Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo. [ Time Frame: 2006 ]
- lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia [ Time Frame: 2007 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947375
|Central Mental Clinic for Outpatients of Baku City|
|Baku, Azerbaijan, AZ0010|
|Principal Investigator:||Nadir A Aliyev, PHD, MD||Outpatient service|