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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Anxious Major Depressive Disorder
Interventions Drug: AZD2327
Drug: Placebo
Enrollment 22
Recruitment Details A single site, randomized, double blind, placebo-controlled, parallel group experimental study. Patients recruited between November 2008 and October 2011.
Pre-assignment Details Screening for eligibility and wash-out of restricted medications.
Arm/Group Title AZD2327 Placebo
Hide Arm/Group Description AZD2327 3mg BID Tablet, Oral, Daily Placebo BID, Tablet, Oral, Daily
Period Title: Overall Study
Started 13 9
Completed 11 7
Not Completed 2 2
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             1             0
Lack of Efficacy             0             2
Arm/Group Title AZD2327 Placebo Total
Hide Arm/Group Description AZD2327 3mg BID Tablet, Oral, Daily Placebo BID, Tablet, Oral, Daily Total of all reporting groups
Overall Number of Baseline Participants 13 9 22
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 9 participants 22 participants
40  (12.2) 48.7  (11.3) 44.35  (11.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 9 participants 22 participants
Female
7
  53.8%
5
  55.6%
12
  54.5%
Male
6
  46.2%
4
  44.4%
10
  45.5%
1.Primary Outcome
Title Hamilton Rating Scale for Depression (HAM-D) Total Score.
Hide Description 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.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD2327 Placebo
Hide Arm/Group Description:
AZD2327 3mg BID Tablet, Oral, Daily
Placebo BID, Tablet, Oral, Daily
Overall Number of Participants Analyzed 13 9
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
14.249  (2.152) 16.307  (2.604)
2.Primary Outcome
Title Hamilton Rating Scale for Anxiety (HAM-A) Total Score.
Hide Description 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.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD2327 Placebo
Hide Arm/Group Description:
AZD2327 3mg BID Tablet, Oral, Daily
Placebo BID, Tablet, Oral, Daily
Overall Number of Participants Analyzed 13 9
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
13.029  (2.257) 17.736  (2.712)
3.Secondary Outcome
Title Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).
Hide Description

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.

Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD2327 Placebo
Hide Arm/Group Description:
AZD2327 3mg BID Tablet, Oral, Daily
Placebo BID, Tablet, Oral, Daily
Overall Number of Participants Analyzed 13 9
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
1.373  (0.313) 2.128  (0.379)
4.Secondary Outcome
Title The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.
Hide Description

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.

Time Frame Randomization to week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD2327 Placebo
Hide Arm/Group Description:
AZD2327 3mg BID Tablet, Oral, Daily
Placebo BID, Tablet, Oral, Daily
Overall Number of Participants Analyzed 13 9
Measure Type: Number
Unit of Measure: Participants
5 4
5.Secondary Outcome
Title The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.
Hide Description

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.

Time Frame Randomization to week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD2327 Placebo
Hide Arm/Group Description:
AZD2327 3mg BID Tablet, Oral, Daily
Placebo BID, Tablet, Oral, Daily
Overall Number of Participants Analyzed 13 9
Measure Type: Number
Unit of Measure: Participants
7 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD2327 Placebo
Hide Arm/Group Description AZD2327 3mg BID Tablet, Oral, Daily Placebo BID, Tablet, Oral, Daily
All-Cause Mortality
AZD2327 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZD2327 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/13 (7.69%)   0/9 (0.00%) 
Vascular disorders     
Hypotension  1/13 (7.69%)  0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD2327 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/13 (100.00%)   9/9 (100.00%) 
Cardiac disorders     
Tachycardia  2/13 (15.38%)  1/9 (11.11%) 
Ear and labyrinth disorders     
Ear Pain  2/13 (15.38%)  1/9 (11.11%) 
Tinnitus  5/13 (38.46%)  2/9 (22.22%) 
Eye disorders     
Vision blurred  1/13 (7.69%)  1/9 (11.11%) 
Eye Irritation  2/13 (15.38%)  5/9 (55.56%) 
Gastrointestinal disorders     
Constipation  6/13 (46.15%)  4/9 (44.44%) 
Diarrhea  3/13 (23.08%)  2/9 (22.22%) 
Flatulence  5/13 (38.46%)  2/9 (22.22%) 
Nausea  5/13 (38.46%)  2/9 (22.22%) 
Abdominal Discomfort  6/13 (46.15%)  2/9 (22.22%) 
Faeces discoloured  1/13 (7.69%)  0/9 (0.00%) 
Vomiting  1/13 (7.69%)  1/9 (11.11%) 
Dry Mouth  9/13 (69.23%)  4/9 (44.44%) 
Gingival Disorder  1/13 (7.69%)  1/9 (11.11%) 
Salivary Hypersecretion  1/13 (7.69%)  1/9 (11.11%) 
Mouth Ulceration  2/13 (15.38%)  2/9 (22.22%) 
Malignant Dysphagia  3/13 (23.08%)  0/9 (0.00%) 
General disorders     
Chest Pain  6/13 (46.15%)  1/9 (11.11%) 
Thirst  6/13 (46.15%)  1/9 (11.11%) 
Oedema  1/13 (7.69%)  1/9 (11.11%) 
Irritability  6/13 (46.15%)  3/9 (33.33%) 
Fatigue  4/13 (30.77%)  2/9 (22.22%) 
Pyrexia  2/13 (15.38%)  1/9 (11.11%) 
Infections and infestations     
Influenza  4/13 (30.77%)  1/9 (11.11%) 
Injury, poisoning and procedural complications     
Injury  1/13 (7.69%)  1/9 (11.11%) 
Investigations     
Weight Increased  8/13 (61.54%)  2/9 (22.22%) 
Weight Decreased  7/13 (53.85%)  4/9 (44.44%) 
Metabolism and nutrition disorders     
Decreased Appetite  5/13 (38.46%)  4/9 (44.44%) 
Increased Appetite  5/13 (38.46%)  2/9 (22.22%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms  2/13 (15.38%)  0/9 (0.00%) 
Muscle Rigidity  3/13 (23.08%)  1/9 (11.11%) 
Myalgia  5/13 (38.46%)  3/9 (33.33%) 
Nervous system disorders     
Dysgeusia  4/13 (30.77%)  1/9 (11.11%) 
Dizziness  7/13 (53.85%)  3/9 (33.33%) 
Headache  9/13 (69.23%)  6/9 (66.67%) 
Akathisia  0/13 (0.00%)  1/9 (11.11%) 
Dyskinesia  1/13 (7.69%)  0/9 (0.00%) 
Tremor  3/13 (23.08%)  0/9 (0.00%) 
Disturbance in attaention  2/13 (15.38%)  1/9 (11.11%) 
Poor quality sleep  5/13 (38.46%)  3/9 (33.33%) 
Memory Impairment  3/13 (23.08%)  2/9 (22.22%) 
Dysarthria  1/13 (7.69%)  0/9 (0.00%) 
Psychiatric disorders     
Libido Decreased  3/13 (23.08%)  0/9 (0.00%) 
Libido Increased  1/13 (7.69%)  0/9 (0.00%) 
Tic  1/13 (7.69%)  0/9 (0.00%) 
Confusional State  1/13 (7.69%)  0/9 (0.00%) 
Depression  2/13 (15.38%)  1/9 (11.11%) 
Initial Insomnia  7/13 (53.85%)  1/9 (11.11%) 
Somnolence  7/13 (53.85%)  3/9 (33.33%) 
Terminal Insomnia  6/13 (46.15%)  2/9 (22.22%) 
Hallucinations  1/13 (7.69%)  0/9 (0.00%) 
Hypokinesia  3/13 (23.08%)  0/9 (0.00%) 
Psychomotor Hyperactivity  5/13 (38.46%)  2/9 (22.22%) 
Suicidal Behavior  1/13 (7.69%)  0/9 (0.00%) 
Suicidal Ideation  2/13 (15.38%)  1/9 (11.11%) 
Renal and urinary disorders     
Pollakiuria  4/13 (30.77%)  0/9 (0.00%) 
Dysuria  0/13 (0.00%)  1/9 (11.11%) 
Reproductive system and breast disorders     
Breast pain  1/13 (7.69%)  0/9 (0.00%) 
Genital Discomfort  1/13 (7.69%)  1/9 (11.11%) 
Menstruation Irregular  0/13 (0.00%)  1/9 (11.11%) 
Premenstrual syndrome  2/13 (15.38%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  2/13 (15.38%)  0/9 (0.00%) 
Dyspnoea  3/13 (23.08%)  1/9 (11.11%) 
Wheezing  3/13 (23.08%)  0/9 (0.00%) 
Nasal Congestion  5/13 (38.46%)  4/9 (44.44%) 
Oropharyngeal Pain  4/13 (30.77%)  2/9 (22.22%) 
Skin and subcutaneous tissue disorders     
Skin irritation  4/13 (30.77%)  3/9 (33.33%) 
Hyperhidrosis  0/13 (0.00%)  1/9 (11.11%) 
Surgical and medical procedures     
Dental Care  0/13 (0.00%)  2/9 (22.22%) 
Vascular disorders     
Hypotension  1/13 (7.69%)  2/9 (22.22%) 
Hypertension  2/13 (15.38%)  0/9 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00759395     History of Changes
Obsolete Identifiers: NCT00738270
Other Study ID Numbers: D0880C00021
First Submitted: September 24, 2008
First Posted: September 25, 2008
Results First Submitted: October 10, 2012
Results First Posted: November 8, 2012
Last Update Posted: November 8, 2012