Lamictal TM, Haloperidol Decanoate in Schizophrenia (CMCOBaku)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo. [ Time Frame: 2006 ] [ Designated as safety issue: Yes ]
- lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia [ Time Frame: 2007 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2005|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
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.
Other Name: Lamictal TMDrug: Haloperidol Decanoate
Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks.
Other Name: Haloperidol Decanoate
No Intervention: Lifestyle councelling
May be required to comply with US Public Law 110-85, Section 801
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947375
|Central Mental Clinic for Outpatients of Baku City|
|Baku, Azerbaijan, AZ0010|
|Principal Investigator:||Nadir A Aliyev, PHD, MD||Outpatient service|