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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00947375 |
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Date of registration:
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20/07/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Lamictal TM, Haloperidol Decanoate in Schizophrenia
CMCOBaku |
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Scientific title:
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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 |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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335 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00947375 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Azerbaijan
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Contacts
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Name:
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Nadir A Aliyev, PHD, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Outpatient service |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Drug: Lamictal TM
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Drug: Haloperidol Decanoate
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Primary Outcome(s)
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Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo.
[Time Frame: 2006]
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Secondary Outcome(s)
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lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia
[Time Frame: 2007]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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