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--- a +++ b/data/NCT00000378.xml @@ -0,0 +1,524 @@ +<clinical_study> + <!-- This xml conforms to an XML Schema at: + https://clinicaltrials.gov/ct2/html/images/info/public.xsd --> + <required_header> + <download_date>ClinicalTrials.gov processed this data on March 05, 2021</download_date> + <link_text>Link to the current ClinicalTrials.gov record.</link_text> + <url>https://clinicaltrials.gov/show/NCT00000378</url> + </required_header> + <id_info> + <org_study_id>#3105</org_study_id> + <secondary_id>R01MH055716</secondary_id> + <nct_id>NCT00000378</nct_id> + </id_info> + <brief_title>Antidepressant Treatment of Melancholia in Late Life</brief_title> + <official_title>Antidepressant Treatment of Melancholia in Late :Ife</official_title> + <sponsors> + <lead_sponsor> + <agency>New York State Psychiatric Institute</agency> + <agency_class>Other</agency_class> + </lead_sponsor> + <collaborator> + <agency>National Institute of Mental Health (NIMH)</agency> + <agency_class>NIH</agency_class> + </collaborator> + </sponsors> + <source>New York State Psychiatric Institute</source> + <oversight_info> + <has_dmc>No</has_dmc> + </oversight_info> + <brief_summary> + <textblock> + The purpose of this study is to compare the safety and effectiveness of a select serotonin
 + re-uptake inhibitor (SSRI, sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in
 + outpatients over the age of 60 who have major depression.
 +
 + SSRIs are effective in the treatment of major depression. However, there is also evidence
 + that SSRIs may be significantly less effective than TCAs for patients with late-life major
 + depression with melancholia. Since SSRIs seem to be easier to take than TCAs and are more
 + widely prescribed, it is important to determine which of these types of antidepressants works
 + best to treat these patients.
 +
 + Patients will be assigned randomly to receive either sertraline (a SSRI) or nortriptyline (a
 + TCA) for 12 weeks. Patients will be monitored for symptoms, side effects, and quality of
 + life. If a patient responds to treatment, he/she will participate in a 6-month continuation
 + phase in which he/she will continue to receive the same medication.
 +
 + An individual may be eligible for this study if he/she:
 +
 + Has unipolar major depression (with some exceptions) and is over 60 years old.
 + </textblock> + </brief_summary> + <detailed_description> + <textblock> + To compare the efficacy and safety of a select serotonin re-uptake inhibitor (SSRI,
 + sertraline) and a tricyclic antidepressant (TCA, nortriptyline) in outpatients over the age
 + of 60 who meet Diagnostic and Statistical Manuel-IV criteria for unipolar major depression,
 + excluding patients who meet criteria for psychotic or atypical subtype. To test the
 + hypothesis that medication condition interacts with diagnostic subtype (melancholic vs
 + non-melancholic) in determining antidepressant response. To examine the roles of symptom
 + severity and alternative diagnostic subtyping in contributing to this pattern.
 +
 + SSRIs are effective in the treatment of major depression. However, there is also evidence
 + that SSRIs may be significantly less effective than TCAs for depressed patients with
 + melancholia. This issue is of particular concern in late-life major depression. SSRIs have
 + important safety advantages with respect to overdose and a benign cardiovascular profile.
 + Furthermore, the SSRIs do not have significant anticholinergic effects, and appear to be
 + better tolerated than the TCAs. Perhaps most important, the SSRIs currently are prescribed
 + widely as the medication treatment of first choice for major depression in late life.
 + Therefore, if it were determined that SSRIs are considerably less effective than TCAs in the
 + treatment of melancholia in the elderly, there would be significant ramifications for
 + clinical practice.
 +
 + Randomization to sertraline (a SSRI) or nortriptyline (a TCA) is stratified by the presence
 + or absence of melancholia. Outcome measures for the 12-week acute phase include clinician and
 + patient ratings of symptoms, side effects, and an evaluation of the health-related quality of
 + life (HRQOL). At the end of the acute treatment phase, patients who meet criteria for
 + clinical response participate in a 6-month continuation phase.
 + </textblock> + </detailed_description> + <overall_status>Completed</overall_status> + <start_date>July 1997</start_date> + <completion_date type="Actual">June 2002</completion_date> + <primary_completion_date type="Actual">June 2002</primary_completion_date> + <phase>Phase 4</phase> + <study_type>Interventional</study_type> + <has_expanded_access>No</has_expanded_access> + <study_design_info> + <allocation>Randomized</allocation> + <intervention_model>Parallel Assignment</intervention_model> + <primary_purpose>Treatment</primary_purpose> + <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking> + </study_design_info> + <primary_outcome> + <measure>HAMILTON Rating Scale for DEPRESSION Range</measure> + <time_frame>BASELINE COMPARED TO 12 WEEK MEASUREMENT</time_frame> + <description>Hamilton scale range 0-40, values below 7 are considered normal. the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement</description> + </primary_outcome> + <number_of_arms>2</number_of_arms> + <enrollment type="Actual">110</enrollment> + <condition>Depression</condition> + <condition>Melancholia</condition> + <arm_group> + <arm_group_label>sertaline</arm_group_label> + <arm_group_type>Active Comparator</arm_group_type> + <description>patients randomized to sertraline 12 week trial does up to 200mgs</description> + </arm_group> + <arm_group> + <arm_group_label>nortriptyline</arm_group_label> + <arm_group_type>Active Comparator</arm_group_type> + <description>patients randomized to nortriptyline dose adjusted to therapeutic level</description> + </arm_group> + <intervention> + <intervention_type>Drug</intervention_type> + <intervention_name>Sertraline</intervention_name> + <description>12 week trial dose up to 200mgs</description> + <arm_group_label>sertaline</arm_group_label> + </intervention> + <intervention> + <intervention_type>Drug</intervention_type> + <intervention_name>Nortriptyline</intervention_name> + <description>12 week trial dose adjusted to therapeutic level</description> + <arm_group_label>nortriptyline</arm_group_label> + <other_name>nortiptyline</other_name> + </intervention> + <eligibility> + <criteria> + <textblock> + Inclusion Criteria:
 +
 + -
 +
 + Patients must have:
 +
 + Unipolar major depression (per Diagnostic and Statistical Manuel-IV criteria) with or
 + without melancholia.
 +
 + Exclusion Criteria:
 +
 + -
 +
 + Patients with the following symptoms or conditions are excluded:
 +
 + Psychotic or atypical subtype of unipolar major depression.
 + </textblock> + </criteria> + <gender>All</gender> + <minimum_age>60 Years</minimum_age> + <maximum_age>95 Years</maximum_age> + <healthy_volunteers>No</healthy_volunteers> + </eligibility> + <overall_official> + <last_name>Steven P. Roose, MD</last_name> + <role>Principal Investigator</role> + <affiliation>New York State Psychiatric Institute</affiliation> + </overall_official> + <location> + <facility> + <name>1051 Riverside Drive</name> + <address> + <city>New York</city> + <state>New York</state> + <zip>10032</zip> + <country>United States</country> + </address> + </facility> + </location> + <location_countries> + <country>United States</country> + </location_countries> + <verification_date>September 2008</verification_date> + <study_first_submitted>November 2, 1999</study_first_submitted> + <study_first_submitted_qc>November 2, 1999</study_first_submitted_qc> + <study_first_posted type="Estimate">November 3, 1999</study_first_posted> + <results_first_submitted>April 2, 2015</results_first_submitted> + <results_first_submitted_qc>April 17, 2015</results_first_submitted_qc> + <results_first_posted type="Estimate">April 21, 2015</results_first_posted> + <last_update_submitted>October 6, 2015</last_update_submitted> + <last_update_submitted_qc>October 6, 2015</last_update_submitted_qc> + <last_update_posted type="Estimate">October 7, 2015</last_update_posted> + <responsible_party> + <responsible_party_type>Sponsor</responsible_party_type> + </responsible_party> + <keyword>Aged</keyword> + <keyword>Antidepressive Agents, Tricyclic</keyword> + <keyword>Depression</keyword> + <keyword>Female</keyword> + <keyword>Human</keyword> + <keyword>Male</keyword> + <keyword>Middle Age</keyword> + <keyword>Nortriptyline</keyword> + <keyword>Sertraline</keyword> + <keyword>Serotonin Uptake Inhibitors</keyword> + <keyword>Antidepressive Agents, Tricyclic -- *therapeutic use</keyword> + <keyword>Antidepressive Agents, Tricyclic -- adverse effects</keyword> + <keyword>Depression -- *drug therapy</keyword> + <keyword>Nortriptyline -- *therapeutic use</keyword> + <keyword>Nortriptyline -- adverse effects</keyword> + <keyword>Sertraline -- *therapeutic use</keyword> + <keyword>Sertraline -- adverse effects</keyword> + <keyword>Serotonin Uptake Inhibitors -- *therapeutic use</keyword> + <keyword>Serotonin Uptake Inhibitors -- adverse effects</keyword> + <condition_browse> + <!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm --> + <mesh_term>Depression</mesh_term> + <mesh_term>Depressive Disorder</mesh_term> + </condition_browse> + <intervention_browse> + <!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm --> + <mesh_term>Sertraline</mesh_term> + <mesh_term>Nortriptyline</mesh_term> + </intervention_browse> + + <clinical_results> + + <participant_flow> + <group_list> + <group group_id="P1"> + <title>Sertaline</title> + <description>patients randomized to sertraline 12 week trial does up to 200mgs
 +Sertraline: 12 week trial dose up to 200mgs</description> + </group> + <group group_id="P2"> + <title>Nortriptyline</title> + <description>patients randomized to nortriptyline dose adjusted to therapeutic level
 +Nortriptyline: 12 week trial dose adjusted to therapeutic level</description> + </group> + </group_list> + <period_list> + <period> + <title>Overall Study</title> + <milestone_list> + <milestone> + <title>STARTED</title> + <participants_list> + <participants group_id="P1" count="58"/> + <participants group_id="P2" count="52"/> + </participants_list> + </milestone> + <milestone> + <title>COMPLETED</title> + <participants_list> + <participants group_id="P1" count="42"/> + <participants group_id="P2" count="38"/> + </participants_list> + </milestone> + <milestone> + <title>NOT COMPLETED</title> + <participants_list> + <participants group_id="P1" count="16"/> + <participants group_id="P2" count="14"/> + </participants_list> + </milestone> + </milestone_list> + <drop_withdraw_reason_list> + <drop_withdraw_reason> + <title>Lack of Efficacy</title> + <participants_list> + <participants group_id="P1" count="16"/> + <participants group_id="P2" count="14"/> + </participants_list> + </drop_withdraw_reason> + </drop_withdraw_reason_list> + </period> + </period_list> + </participant_flow> + + <baseline> + <group_list> + <group group_id="B1"> + <title>Sertaline</title> + <description>patients randomized to sertraline 12 week trial does up to 200mgs
 +Sertraline: 12 week trial dose up to 200mgs</description> + </group> + <group group_id="B2"> + <title>Nortriptyline</title> + <description>patients randomized to nortriptyline dose adjusted to therapeutic level
 +Nortriptyline: 12 week trial dose adjusted to therapeutic level</description> + </group> + <group group_id="B3"> + <title>Total</title> + <description>Total of all reporting groups</description> + </group> + </group_list> + <analyzed_list> + <analyzed> + <units>Participants</units> + <scope>Overall</scope> + <count_list> + <count group_id="B1" value="58"/> + <count group_id="B2" value="52"/> + <count group_id="B3" value="110"/> + </count_list> + </analyzed> + </analyzed_list> + <measure_list> + <measure> + <title>Age</title> + <units>Participants</units> + <param>Count of Participants</param> + <class_list> + <class> + <category_list> + <category> + <title><=18 years</title> + <measurement_list> + <measurement group_id="B1" value="0"/> + <measurement group_id="B2" value="0"/> + <measurement group_id="B3" value="0"/> + </measurement_list> + </category> + <category> + <title>Between 18 and 65 years</title> + <measurement_list> + <measurement group_id="B1" value="8"/> + <measurement group_id="B2" value="4"/> + <measurement group_id="B3" value="12"/> + </measurement_list> + </category> + <category> + <title>>=65 years</title> + <measurement_list> + <measurement group_id="B1" value="50"/> + <measurement group_id="B2" value="48"/> + <measurement group_id="B3" value="98"/> + </measurement_list> + </category> + </category_list> + </class> + </class_list> + </measure> + <measure> + <title>Sex: Female, Male</title> + <units>Participants</units> + <param>Count of Participants</param> + <class_list> + <class> + <category_list> + <category> + <title>Female</title> + <measurement_list> + <measurement group_id="B1" value="34"/> + <measurement group_id="B2" value="30"/> + <measurement group_id="B3" value="64"/> + </measurement_list> + </category> + <category> + <title>Male</title> + <measurement_list> + <measurement group_id="B1" value="24"/> + <measurement group_id="B2" value="22"/> + <measurement group_id="B3" value="46"/> + </measurement_list> + </category> + </category_list> + </class> + </class_list> + </measure> + <measure> + <title>Region of Enrollment</title> + <units>participants</units> + <param>Number</param> + <class_list> + <class> + <title>United States</title> + <category_list> + <category> + <measurement_list> + <measurement group_id="B1" value="58"/> + <measurement group_id="B2" value="52"/> + <measurement group_id="B3" value="110"/> + </measurement_list> + </category> + </category_list> + </class> + </class_list> + </measure> + </measure_list> + </baseline> + + <outcome_list> + <outcome> + <type>Primary</type> + <title>HAMILTON Rating Scale for DEPRESSION Range</title> + <description>Hamilton scale range 0-40, values below 7 are considered normal. the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement</description> + <time_frame>BASELINE COMPARED TO 12 WEEK MEASUREMENT</time_frame> + <population>intent to treat analysis</population> + <group_list> + <group group_id="O1"> + <title>Sertaline</title> + <description>patients randomized to sertraline 12 week trial does up to 200mgs
 +Sertraline: 12 week trial dose up to 200mgs</description> + </group> + <group group_id="O2"> + <title>Nortriptyline</title> + <description>patients randomized to nortriptyline dose adjusted to therapeutic level
 +Nortriptyline: 12 week trial dose adjusted to therapeutic level</description> + </group> + </group_list> + <measure> + <title>HAMILTON Rating Scale for DEPRESSION Range</title> + <description>Hamilton scale range 0-40, values below 7 are considered normal. the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement</description> + <population>intent to treat analysis</population> + <units>units on a scale</units> + <param>Mean</param> + <dispersion>Standard Deviation</dispersion> + <analyzed_list> + <analyzed> + <units>Participants</units> + <scope>Measure</scope> + <count_list> + <count group_id="O1" value="58"/> + <count group_id="O2" value="52"/> + </count_list> + </analyzed> + </analyzed_list> + <class_list> + <class> + <title>BASELINE</title> + <category_list> + <category> + <measurement_list> + <measurement group_id="O1" value="27.3" spread="6.6"/> + <measurement group_id="O2" value="27.1" spread="4.4"/> + </measurement_list> + </category> + </category_list> + </class> + <class> + <title>12 WEEK DATA</title> + <category_list> + <category> + <measurement_list> + <measurement group_id="O1" value="10.7" spread="8.3"/> + <measurement group_id="O2" value="8.4" spread="7.7"/> + </measurement_list> + </category> + </category_list> + </class> + </class_list> + </measure> + <analysis_list> + <analysis> + <group_id_list> + <group_id>O1</group_id> + <group_id>O2</group_id> + </group_id_list> + <groups_desc>logistic regression and mixed effects model</groups_desc> + <non_inferiority_type>Superiority or Other</non_inferiority_type> + <p_value><0.05</p_value> + <p_value_desc>actual calculation</p_value_desc> + <method>Regression, Logistic</method> + </analysis> + </analysis_list> + </outcome> + </outcome_list> + + <reported_events> + <group_list> + <group group_id="E1"> + <title>Sertaline</title> + <description>patients randomized to sertraline 12 week trial does up to 200mgs
 +Sertraline: 12 week trial dose up to 200mgs</description> + </group> + <group group_id="E2"> + <title>Nortriptyline</title> + <description>patients randomized to nortriptyline dose adjusted to therapeutic level
 +Nortriptyline: 12 week trial dose adjusted to therapeutic level</description> + </group> + </group_list> + <serious_events> + <category_list> + <category> + <title>Total</title> + <event_list> + <event> + <sub_title>Total, serious adverse events</sub_title> + <counts group_id="E1" subjects_affected="0" subjects_at_risk="58"/> + <counts group_id="E2" subjects_affected="0" subjects_at_risk="52"/> + </event> + </event_list> + </category> + </category_list> + </serious_events> + <other_events> + <frequency_threshold>5</frequency_threshold> + <default_assessment>Systematic Assessment</default_assessment> + <category_list> + <category> + <title>Total</title> + <event_list> + <event> + <sub_title>Total, other adverse events</sub_title> + <counts group_id="E1" subjects_affected="2" subjects_at_risk="58"/> + <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/> + </event> + </event_list> + </category> + <category> + <title>Cardiac disorders</title> + <event_list> + <event> + <sub_title>orthostatic hypotension</sub_title> + <counts group_id="E1" subjects_affected="2" subjects_at_risk="58"/> + <counts group_id="E2" subjects_affected="4" subjects_at_risk="52"/> + </event> + </event_list> + </category> + </category_list> + </other_events> + </reported_events> + + <certain_agreements> + <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee> + <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement> + </certain_agreements> + <point_of_contact> + <name_or_title>Steven Roose MD</name_or_title> + <organization>New York State Psychiatric Institute</organization> + <phone>646-774-8661</phone> + <email>spr2@columbia.edu</email> + </point_of_contact> + </clinical_results> +</clinical_study> +