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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: |
NCT00576095 |
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Date of registration:
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14/12/2007 |
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Primary sponsor: |
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Public title:
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Clinical and Biological Characteristics of Psychotic Depression
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Scientific title:
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Hypothalamic-Pituitary-Adrenal (HPA)/ Dopamine Axis in Psychotic Depression |
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Date of first enrolment:
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August 2005 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00576095 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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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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Lakshika Tennakoon |
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Address:
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Telephone:
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650-723-3305 |
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Email:
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lakshika@stanford.edu |
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Affiliation:
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Name:
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Lakshika Tennakoon |
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Address:
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Telephone:
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(650) 723-3305 |
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Email:
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lakshika@stanford.edu |
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Affiliation:
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Name:
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Alan Schatzberg |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stanford University |
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Name:
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Jennifer Keller |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stanford University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:Inclusion criteria for PMD (individuals with Psychotic Major
Depression) and NPMDs (individuals with Non-Psychotic Major Depression) are as follows:
1. DSM IV diagnosis of Major Depressive Disorder with or without psychotic features,
Bipolar II Disorder with or without psychotic features in a major depressive episode.
2. 21-item HAM-D score greater than or equal to 21.
3. Thase Core Endogenomorphic Scale score greater than or equal to 6 on the items
included in the 21-item HDRS.
4. Between 21 - 85 years of age.
5. If currently taking antipsychotic, antidepressant, anticonvulsant, and/or
mood-stabilizing medications, must be stable on the medication for at least one-week
prior to entering the study.
6. Pre-existing (current) primary treating psychiatrist for subjects with psychotic
features.
7. Any secondary diagnoses from the anxiety disorder spectrum is acceptable. Primary
pre-existing chronic Obsessive-Compulsive Disorder(OCD) will be an exclusion
criteria.
Inclusion criteria for healthy controls are as follows:
1. Between 21 - 85 years of age.
2. Taking no medications
3. Have a HAM-D score of less than or equal to 5.
Exclusion Criteria:Exclusion criteria for PMDs and NPMDs are as follows:
1. ECT in the 4 months prior to the study.
2. Abuse of drugs or alcohol in the 6 months prior to study.
3. Unstable or untreated hypertension, or cardiovascular disease.
4. If participating in the blood draw portion of the protocol, endocrine disorders are
exclusionary.
5. Use of additional prescription medications, street drugs, or alcohol during the week
before the study.
6. Any Axis II diagnosis or traits which would make participation in the study
difficult.
7. Current pregnancy or lactation.
Exclusion criteria for healthy controls:
1. Personal history of Axis I or Axis II disorders.
2. Active unstable medical problems.
3. Abuse of drugs or alcohol in the 6 months prior to study.
4. Use of additional prescription medications, street drugs, or alcohol during the week
before the study.
5. Currently pregnant or lactating.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Depression
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Depressive Disorder, Major
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Psychotic Disorders
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Secondary ID(s)
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2 R01 MH050604-10
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MH50604
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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