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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01134731 |
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Date of registration:
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20/05/2010 |
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Primary sponsor: |
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Public title:
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Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation
AFSP |
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Scientific title:
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Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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69 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01134731 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Roberta S May, MA |
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Address:
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Telephone:
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205-934-2605 |
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Email:
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bmay@uab.edu |
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Affiliation:
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Name:
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Roberta S May, MA |
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Address:
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Telephone:
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205-934-2605 |
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Email:
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bmay@uab.edu |
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Affiliation:
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Name:
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Richard C Shelton, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alabama at Birmingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 19-65 years of age
2. Diagnosis of major depressive disorder
3. Currently experiencing suicidal thoughts
Exclusion Criteria:
1. Depressed patients without suicidality
2. Patients with severe psychotic features or with primary diagnoses of bipolar
disorder, schizoaffective disorder, schizophrenia, substance abuse/dependence or
generalized anxiety
3. Subjects who have taken lithium or an antipsychotic in the last 2 weeks
4. pregnant women.
Age minimum:
19 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorder
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Suicidality
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Intervention(s)
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Drug: lithium
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Drug: paliperidone
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Drug: placebo
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Primary Outcome(s)
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Paliperidone and Lithium in the treatment of suicidality - treatment indication and epigenetic regulation
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Paliperidone and Lithium in the treatment of suicidality - treatment indication and epigenetic regulation
[Time Frame: 12 weeks]
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Secondary ID(s)
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F100329001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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