- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00947375
Lamictal TM, Haloperidol Decanoate in Schizophrenia (CMCOBaku)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Baku, Azerbaijan, AZ0010
- Central Mental Clinic for Outpatients of Baku City
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Starch
In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial.
|
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.
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo.
Time Frame: 2006
|
2006
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia
Time Frame: 2007
|
2007
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nadir A Aliyev, PHD, MD, Outpatient service
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Antagonists
- Anticonvulsants
- Sodium Channel Blockers
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Anti-Dyskinesia Agents
- Lamotrigine
- Haloperidol
- Haloperidol decanoate
Other Study ID Numbers
- Nadir
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingTreatment-resistant SchizophreniaUnited States
Clinical Trials on Lamictal TM
-
Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH); Atrium...CompletedVentral Hernia | AdhesionsUnited States
-
NephroSantNot yet recruitingKidney Transplant Failure and Rejection
-
University Hospital TuebingenTerminatedApnea of Prematurity | Continuous Positive Airway Pressure | CPAP
-
Ivoclar Vivadent AGNot yet recruitingClass I or II Cavities in Premolars or Molars
-
Tufts UniversityBioElectronics CorporationTerminatedPostoperative Edema and PainUnited States
-
Boston UniversityNational Institute of Dental and Craniofacial Research (NIDCR)Not yet recruitingHIV Infections
-
BioTech Tools S.A.Completed
-
Zimmer BiometActive, not recruitingOsteoarthritis | Rheumatoid Arthritis | Avascular Necrosis | Post-traumatic Arthritis | Revision Total Shoulder Arthroplasty | Ununited Humeral Head Fracture | Irreducible 3-and 4-part Proximal Humeral Fractures | Gross Rotator Cuff DeficiencyUnited States, United Kingdom
-
BioStream Technologies, LLCCompletedAutism Spectrum DisorderUnited States
-
RWTH Aachen UniversityUniversity of ChicagoCompleted