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Trial record 3 of 1913 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder

Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)

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ClinicalTrials.gov Identifier: NCT00759395
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : November 8, 2012
Last Update Posted : November 8, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE September 24, 2008
First Posted Date  ICMJE September 25, 2008
Results First Submitted Date  ICMJE October 10, 2012
Results First Posted Date  ICMJE November 8, 2012
Last Update Posted Date November 8, 2012
Study Start Date  ICMJE January 2009
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
  • Hamilton Rating Scale for Depression (HAM-D) Total Score. [ Time Frame: Week 4 ]
    Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
  • Hamilton Rating Scale for Anxiety (HAM-A) Total Score. [ Time Frame: Week 4 ]
    The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2008)
  • To determine if AZD2327 is effective in the treatment of AMDD in adult men and women as assessed by the Hamilton Rating Scale for Depression [ Time Frame: At screening, pre-treatment, 5 days (4 per day) during in-patient, 4 times during out-patient, and 1 follow up. ]
  • To determine if AZD2327 is effective in the treatment of AMDD in adult men and women as assessed by theHamilton Rating Scale for Anxiety [ Time Frame: At screening, pre-treatment, 5 days (4 per day) during in-patient, 4 times during out-patient, and 1 follow up. ]
Change History Complete list of historical versions of study NCT00759395 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
  • Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D). [ Time Frame: Week 4 ]
    Psychic anxiety item of the Hamilton Rating Scale for Depression (HAM-D) (item 10, 0-4 units), 0 is considered the best outcome. Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
  • The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score. [ Time Frame: Randomization to week 4 ]
    Hamilton Rating Scale for Depression (HAM-D) response is defined as a >= 50% reduction from randomization (baseline) in HAM-D total score. Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
  • The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score. [ Time Frame: Randomization to week 4 ]
    Hamilton Rating Scale for Anxiety (HAM-A) response is defined as a >= 50% reduction from randomization (baseline) in HAM-A total score. The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2008)
To assess the safety and tolerability of AZD2327 in patients with AMDD as assessed by vital signs, physician exams, labs, ECGs, EEGs, incidence of adverse events and orthostatic challenges. [ Time Frame: To determine if AZD2327 is effective in the treatment of AMDD in adult men and women as assessed by theHamilton Rating Scale for Anxiety ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)
Official Title  ICMJE An Investigation of the Antidepressant Efficacy of a Selective, High, Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder
Brief Summary This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Anxious Major Depressive Disorder
Intervention  ICMJE
  • Drug: AZD2327
    Tablet, Oral, Daily
  • Drug: Placebo
    Tablet, Oral, Daily
Study Arms  ICMJE
  • Experimental: AZD2327
    AZD2327 3mg BID
    Intervention: Drug: AZD2327
  • Placebo Comparator: Placebo
    Placebo BID
    Intervention: Drug: Placebo
Publications * Richards EM, Mathews DC, Luckenbaugh DA, Ionescu DF, Machado-Vieira R, Niciu MJ, Duncan WC, Nolan NM, Franco-Chaves JA, Hudzik T, Maciag C, Li S, Cross A, Smith MA, Zarate CA Jr. A randomized, placebo-controlled pilot trial of the delta opioid receptor agonist AZD2327 in anxious depression. Psychopharmacology (Berl). 2016 Mar;233(6):1119-30. doi: 10.1007/s00213-015-4195-4. Epub 2016 Jan 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2012)
22
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2008)
80
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Diagnosis of major depressive disorder without psychotic features (MDD)

Exclusion Criteria:

  • A history of substance or alcohol abuse within the past 6 months or dependence within 1 year of enrollment as defined by DSM-IV criteria.
  • Women that are pregnant or lactating
  • History of pancreatitis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00759395
Other Study ID Numbers  ICMJE D0880C00021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark Smith, MD AstraZeneca
Principal Investigator: Carlos Zarate National Institute of Mental Health (NIMH)
PRS Account AstraZeneca
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP