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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|