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
Results First Received: October 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Anxious Major Depressive Disorder
Interventions: Drug: AZD2327
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A single site, randomized, double blind, placebo-controlled, parallel group experimental study. Patients recruited between November 2008 and October 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for eligibility and wash-out of restricted medications.

Reporting Groups
  Description
AZD2327 AZD2327 3mg BID Tablet, Oral, Daily
Placebo Placebo BID, Tablet, Oral, Daily

Participant Flow:   Overall Study
    AZD2327     Placebo  
STARTED     13     9  
COMPLETED     11     7  
NOT COMPLETED     2     2  
Adverse Event                 1                 0  
Withdrawal by Subject                 1                 0  
Lack of Efficacy                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AZD2327 AZD2327 3mg BID Tablet, Oral, Daily
Placebo Placebo BID, Tablet, Oral, Daily
Total Total of all reporting groups

Baseline Measures
    AZD2327     Placebo     Total  
Number of Participants  
[units: participants]
  13     9     22  
Age  
[units: Years]
Mean ± Standard Deviation
  40  ± 12.2     48.7  ± 11.3     44.35  ± 11.75  
Gender  
[units: Participants]
     
Female     7     5     12  
Male     6     4     10  



  Outcome Measures
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1.  Primary:   Hamilton Rating Scale for Depression (HAM-D) Total Score.   [ Time Frame: Week 4 ]

2.  Primary:   Hamilton Rating Scale for Anxiety (HAM-A) Total Score.   [ Time Frame: Week 4 ]

3.  Secondary:   Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).   [ Time Frame: Week 4 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
AZD2327 AZD2327 3mg BID Tablet, Oral, Daily
Placebo Placebo BID, Tablet, Oral, Daily

Other Adverse Events
    AZD2327     Placebo  
Total, other (not including serious) adverse events      
# participants affected / at risk     13/13     9/9  
Cardiac disorders      
Tachycardia      
# participants affected / at risk     2/13 (15.38%)     1/9 (11.11%)  
Ear and labyrinth disorders      
Ear Pain      
# participants affected / at risk     2/13 (15.38%)     1/9 (11.11%)  
Tinnitus      
# participants affected / at risk     5/13 (38.46%)     2/9 (22.22%)  
Eye disorders      
Vision blurred      
# participants affected / at risk     1/13 (7.69%)     1/9 (11.11%)  
Eye Irritation      
# participants affected / at risk     2/13 (15.38%)     5/9 (55.56%)  
Gastrointestinal disorders      
Constipation      
# participants affected / at risk     6/13 (46.15%)     4/9 (44.44%)  
Diarrhea      
# participants affected / at risk     3/13 (23.08%)     2/9 (22.22%)  
Flatulence      
# participants affected / at risk     5/13 (38.46%)     2/9 (22.22%)  
Nausea      
# participants affected / at risk     5/13 (38.46%)     2/9 (22.22%)  
Abdominal Discomfort      
# participants affected / at risk     6/13 (46.15%)     2/9 (22.22%)  
Faeces discoloured      
# participants affected / at risk     1/13 (7.69%)     0/9 (0.00%)  
Vomiting      
# participants affected / at risk     1/13 (7.69%)     1/9 (11.11%)  
Dry Mouth      
# participants affected / at risk     9/13 (69.23%)     4/9 (44.44%)  
Gingival Disorder      
# participants affected / at risk     1/13 (7.69%)     1/9 (11.11%)  
Salivary Hypersecretion      
# participants affected / at risk     1/13 (7.69%)     1/9 (11.11%)  
Mouth Ulceration      
# participants affected / at risk     2/13 (15.38%)     2/9 (22.22%)  
Malignant Dysphagia      
# participants affected / at risk     3/13 (23.08%)     0/9 (0.00%)  
General disorders      
Chest Pain      
# participants affected / at risk     6/13 (46.15%)     1/9 (11.11%)  
Thirst      
# participants affected / at risk     6/13 (46.15%)     1/9 (11.11%)  
Oedema      
# participants affected / at risk     1/13 (7.69%)     1/9 (11.11%)  
Irritability      
# participants affected / at risk     6/13 (46.15%)     3/9 (33.33%)  
Fatigue      
# participants affected / at risk     4/13 (30.77%)     2/9 (22.22%)  
Pyrexia      
# participants affected / at risk     2/13 (15.38%)     1/9 (11.11%)  
Infections and infestations      
Influenza      
# participants affected / at risk     4/13 (30.77%)     1/9 (11.11%)  
Injury, poisoning and procedural complications      
Injury      
# participants affected / at risk     1/13 (7.69%)     1/9 (11.11%)  
Investigations      
Weight Increased      
# participants affected / at risk     8/13 (61.54%)     2/9 (22.22%)  
Weight Decreased      
# participants affected / at risk     7/13 (53.85%)     4/9 (44.44%)  
Metabolism and nutrition disorders      
Decreased Appetite      
# participants affected / at risk     5/13 (38.46%)     4/9 (44.44%)  
Increased Appetite      
# participants affected / at risk     5/13 (38.46%)     2/9 (22.22%)  
Musculoskeletal and connective tissue disorders      
Muscle spasms      
# participants affected / at risk     2/13 (15.38%)     0/9 (0.00%)  
Muscle Rigidity      
# participants affected / at risk     3/13 (23.08%)     1/9 (11.11%)  
Myalgia      
# participants affected / at risk     5/13 (38.46%)     3/9 (33.33%)  
Nervous system disorders      
Dysgeusia      
# participants affected / at risk     4/13 (30.77%)     1/9 (11.11%)  
Dizziness      
# participants affected / at risk     7/13 (53.85%)     3/9 (33.33%)  
Headache      
# participants affected / at risk     9/13 (69.23%)     6/9 (66.67%)  
Akathisia      
# participants affected / at risk     0/13 (0.00%)     1/9 (11.11%)  
Dyskinesia      
# participants affected / at risk     1/13 (7.69%)     0/9 (0.00%)  
Tremor      
# participants affected / at risk     3/13 (23.08%)     0/9 (0.00%)  
Disturbance in attaention      
# participants affected / at risk     2/13 (15.38%)     1/9 (11.11%)  
Poor quality sleep      
# participants affected / at risk     5/13 (38.46%)     3/9 (33.33%)  
Memory Impairment      
# participants affected / at risk     3/13 (23.08%)     2/9 (22.22%)  
Dysarthria      
# participants affected / at risk     1/13 (7.69%)     0/9 (0.00%)  
Psychiatric disorders      
Libido Decreased      
# participants affected / at risk     3/13 (23.08%)     0/9 (0.00%)  
Libido Increased      
# participants affected / at risk     1/13 (7.69%)     0/9 (0.00%)  
Tic      
# participants affected / at risk     1/13 (7.69%)     0/9 (0.00%)  
Confusional State      
# participants affected / at risk     1/13 (7.69%)     0/9 (0.00%)  
Depression      
# participants affected / at risk     2/13 (15.38%)     1/9 (11.11%)  
Initial Insomnia      
# participants affected / at risk     7/13 (53.85%)     1/9 (11.11%)  
Somnolence      
# participants affected / at risk     7/13 (53.85%)     3/9 (33.33%)  
Terminal Insomnia      
# participants affected / at risk     6/13 (46.15%)     2/9 (22.22%)  
Hallucinations      
# participants affected / at risk     1/13 (7.69%)     0/9 (0.00%)  
Hypokinesia      
# participants affected / at risk     3/13 (23.08%)     0/9 (0.00%)  
Psychomotor Hyperactivity      
# participants affected / at risk     5/13 (38.46%)     2/9 (22.22%)  
Suicidal Behavior      
# participants affected / at risk     1/13 (7.69%)     0/9 (0.00%)  
Suicidal Ideation      
# participants affected / at risk     2/13 (15.38%)     1/9 (11.11%)  
Renal and urinary disorders      
Pollakiuria      
# participants affected / at risk     4/13 (30.77%)     0/9 (0.00%)  
Dysuria      
# participants affected / at risk     0/13 (0.00%)     1/9 (11.11%)  
Reproductive system and breast disorders      
Breast pain      
# participants affected / at risk     1/13 (7.69%)     0/9 (0.00%)  
Genital Discomfort      
# participants affected / at risk     1/13 (7.69%)     1/9 (11.11%)  
Menstruation Irregular      
# participants affected / at risk     0/13 (0.00%)     1/9 (11.11%)  
Premenstrual syndrome      
# participants affected / at risk     2/13 (15.38%)     0/9 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Cough      
# participants affected / at risk     2/13 (15.38%)     0/9 (0.00%)  
Dyspnoea      
# participants affected / at risk     3/13 (23.08%)     1/9 (11.11%)  
Wheezing      
# participants affected / at risk     3/13 (23.08%)     0/9 (0.00%)  
Nasal Congestion      
# participants affected / at risk     5/13 (38.46%)     4/9 (44.44%)  
Oropharyngeal Pain      
# participants affected / at risk     4/13 (30.77%)     2/9 (22.22%)  
Skin and subcutaneous tissue disorders      
Skin irritation      
# participants affected / at risk     4/13 (30.77%)     3/9 (33.33%)  
Hyperhidrosis      
# participants affected / at risk     0/13 (0.00%)     1/9 (11.11%)  
Surgical and medical procedures      
Dental Care      
# participants affected / at risk     0/13 (0.00%)     2/9 (22.22%)  
Vascular disorders      
Hypotension      
# participants affected / at risk     1/13 (7.69%)     2/9 (22.22%)  
Hypertension      
# participants affected / at risk     2/13 (15.38%)     0/9 (0.00%)  



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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