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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00759395
First received: September 24, 2008
Last updated: October 10, 2012
Last verified: October 2012

September 24, 2008
October 10, 2012
January 2009
October 2011   (final data collection date for primary outcome measure)
  • Hamilton Rating Scale for Depression (HAM-D) Total Score. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • 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. ] [ Designated as safety issue: No ]
  • 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. ]
Complete list of historical versions of study NCT00759395 on ClinicalTrials.gov Archive Site
  • Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D). [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.

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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)
An Investigation of the Antidepressant Efficacy of a Selective, High, Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder

This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Anxious Major Depressive Disorder
  • Drug: AZD2327
    Tablet, Oral, Daily
  • Drug: Placebo
    Tablet, Oral, Daily
  • Experimental: AZD2327
    AZD2327 3mg BID
    Intervention: Drug: AZD2327
  • Placebo Comparator: Placebo
    Placebo BID
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00759395
D0880C00021
Yes
AstraZeneca
AstraZeneca
Not Provided
Study Director: Mark Smith, MD AstraZeneca
Principal Investigator: Carlos Zarate National Institute of Mental Health (NIMH)
AstraZeneca
October 2012

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