Trial Outcomes & Findings for Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD) (NCT NCT00759395)
NCT ID: NCT00759395
Last Updated: 2012-11-08
Results Overview
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.
COMPLETED
PHASE2
22 participants
Week 4
2012-11-08
Participant Flow
A single site, randomized, double blind, placebo-controlled, parallel group experimental study. Patients recruited between November 2008 and October 2011.
Screening for eligibility and wash-out of restricted medications.
Participant milestones
| Measure |
AZD2327
AZD2327 3mg BID Tablet, Oral, Daily
|
Placebo
Placebo BID, Tablet, Oral, Daily
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
9
|
|
Overall Study
COMPLETED
|
11
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
AZD2327
AZD2327 3mg BID Tablet, Oral, Daily
|
Placebo
Placebo BID, Tablet, Oral, Daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
Baseline Characteristics
Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)
Baseline characteristics by cohort
| Measure |
AZD2327
n=13 Participants
AZD2327 3mg BID Tablet, Oral, Daily
|
Placebo
n=9 Participants
Placebo BID, Tablet, Oral, Daily
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
40 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
48.7 Years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
44.35 Years
STANDARD_DEVIATION 11.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4Hamilton 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.
Outcome measures
| Measure |
AZD2327
n=13 Participants
AZD2327 3mg BID Tablet, Oral, Daily
|
Placebo
n=9 Participants
Placebo BID, Tablet, Oral, Daily
|
|---|---|---|
|
Hamilton Rating Scale for Depression (HAM-D) Total Score.
|
14.249 Units on a scale
Standard Error 2.152
|
16.307 Units on a scale
Standard Error 2.604
|
PRIMARY outcome
Timeframe: Week 4The 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.
Outcome measures
| Measure |
AZD2327
n=13 Participants
AZD2327 3mg BID Tablet, Oral, Daily
|
Placebo
n=9 Participants
Placebo BID, Tablet, Oral, Daily
|
|---|---|---|
|
Hamilton Rating Scale for Anxiety (HAM-A) Total Score.
|
13.029 Units on a scale
Standard Error 2.257
|
17.736 Units on a scale
Standard Error 2.712
|
SECONDARY outcome
Timeframe: Week 4Psychic 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.
Outcome measures
| Measure |
AZD2327
n=13 Participants
AZD2327 3mg BID Tablet, Oral, Daily
|
Placebo
n=9 Participants
Placebo BID, Tablet, Oral, Daily
|
|---|---|---|
|
Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).
|
1.373 Units on a scale
Standard Error 0.313
|
2.128 Units on a scale
Standard Error 0.379
|
SECONDARY outcome
Timeframe: Randomization to week 4Hamilton 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.
Outcome measures
| Measure |
AZD2327
n=13 Participants
AZD2327 3mg BID Tablet, Oral, Daily
|
Placebo
n=9 Participants
Placebo BID, Tablet, Oral, Daily
|
|---|---|---|
|
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Randomization to week 4Hamilton 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.
Outcome measures
| Measure |
AZD2327
n=13 Participants
AZD2327 3mg BID Tablet, Oral, Daily
|
Placebo
n=9 Participants
Placebo BID, Tablet, Oral, Daily
|
|---|---|---|
|
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.
|
7 Participants
|
3 Participants
|
Adverse Events
AZD2327
Placebo
Serious adverse events
| Measure |
AZD2327
n=13 participants at risk
AZD2327 3mg BID Tablet, Oral, Daily
|
Placebo
n=9 participants at risk
Placebo BID, Tablet, Oral, Daily
|
|---|---|---|
|
Vascular disorders
Hypotension
|
7.7%
1/13
|
0.00%
0/9
|
Other adverse events
| Measure |
AZD2327
n=13 participants at risk
AZD2327 3mg BID Tablet, Oral, Daily
|
Placebo
n=9 participants at risk
Placebo BID, Tablet, Oral, Daily
|
|---|---|---|
|
Vascular disorders
Hypotension
|
7.7%
1/13
|
22.2%
2/9
|
|
Cardiac disorders
Tachycardia
|
15.4%
2/13
|
11.1%
1/9
|
|
General disorders
Chest Pain
|
46.2%
6/13
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.1%
3/13
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
23.1%
3/13
|
0.00%
0/9
|
|
Vascular disorders
Hypertension
|
15.4%
2/13
|
0.00%
0/9
|
|
Reproductive system and breast disorders
Breast pain
|
7.7%
1/13
|
0.00%
0/9
|
|
Ear and labyrinth disorders
Ear Pain
|
15.4%
2/13
|
11.1%
1/9
|
|
Ear and labyrinth disorders
Tinnitus
|
38.5%
5/13
|
22.2%
2/9
|
|
Eye disorders
Vision blurred
|
7.7%
1/13
|
11.1%
1/9
|
|
Eye disorders
Eye Irritation
|
15.4%
2/13
|
55.6%
5/9
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
38.5%
5/13
|
44.4%
4/9
|
|
Metabolism and nutrition disorders
Increased Appetite
|
38.5%
5/13
|
22.2%
2/9
|
|
Gastrointestinal disorders
Constipation
|
46.2%
6/13
|
44.4%
4/9
|
|
Gastrointestinal disorders
Diarrhea
|
23.1%
3/13
|
22.2%
2/9
|
|
Gastrointestinal disorders
Flatulence
|
38.5%
5/13
|
22.2%
2/9
|
|
General disorders
Thirst
|
46.2%
6/13
|
11.1%
1/9
|
|
Renal and urinary disorders
Pollakiuria
|
30.8%
4/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Nausea
|
38.5%
5/13
|
22.2%
2/9
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
46.2%
6/13
|
22.2%
2/9
|
|
Gastrointestinal disorders
Faeces discoloured
|
7.7%
1/13
|
0.00%
0/9
|
|
Nervous system disorders
Dysgeusia
|
30.8%
4/13
|
11.1%
1/9
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13
|
11.1%
1/9
|
|
Investigations
Weight Increased
|
61.5%
8/13
|
22.2%
2/9
|
|
Investigations
Weight Decreased
|
53.8%
7/13
|
44.4%
4/9
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.4%
2/13
|
0.00%
0/9
|
|
Psychiatric disorders
Libido Decreased
|
23.1%
3/13
|
0.00%
0/9
|
|
Reproductive system and breast disorders
Genital Discomfort
|
7.7%
1/13
|
11.1%
1/9
|
|
Psychiatric disorders
Libido Increased
|
7.7%
1/13
|
0.00%
0/9
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
0.00%
0/13
|
11.1%
1/9
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13
|
11.1%
1/9
|
|
Reproductive system and breast disorders
Premenstrual syndrome
|
15.4%
2/13
|
0.00%
0/9
|
|
Nervous system disorders
Dizziness
|
53.8%
7/13
|
33.3%
3/9
|
|
Nervous system disorders
Headache
|
69.2%
9/13
|
66.7%
6/9
|
|
Surgical and medical procedures
Dental Care
|
0.00%
0/13
|
22.2%
2/9
|
|
Gastrointestinal disorders
Dry Mouth
|
69.2%
9/13
|
44.4%
4/9
|
|
Gastrointestinal disorders
Gingival Disorder
|
7.7%
1/13
|
11.1%
1/9
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
7.7%
1/13
|
11.1%
1/9
|
|
Gastrointestinal disorders
Mouth Ulceration
|
15.4%
2/13
|
22.2%
2/9
|
|
Nervous system disorders
Akathisia
|
0.00%
0/13
|
11.1%
1/9
|
|
Nervous system disorders
Dyskinesia
|
7.7%
1/13
|
0.00%
0/9
|
|
General disorders
Oedema
|
7.7%
1/13
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Muscle Rigidity
|
23.1%
3/13
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
38.5%
5/13
|
33.3%
3/9
|
|
Psychiatric disorders
Tic
|
7.7%
1/13
|
0.00%
0/9
|
|
Nervous system disorders
Tremor
|
23.1%
3/13
|
0.00%
0/9
|
|
Gastrointestinal disorders
Malignant Dysphagia
|
23.1%
3/13
|
0.00%
0/9
|
|
Infections and infestations
Influenza
|
30.8%
4/13
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
38.5%
5/13
|
44.4%
4/9
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
30.8%
4/13
|
22.2%
2/9
|
|
Nervous system disorders
Disturbance in attaention
|
15.4%
2/13
|
11.1%
1/9
|
|
Psychiatric disorders
Confusional State
|
7.7%
1/13
|
0.00%
0/9
|
|
Psychiatric disorders
Depression
|
15.4%
2/13
|
11.1%
1/9
|
|
Psychiatric disorders
Initial Insomnia
|
53.8%
7/13
|
11.1%
1/9
|
|
Psychiatric disorders
Somnolence
|
53.8%
7/13
|
33.3%
3/9
|
|
Psychiatric disorders
Terminal Insomnia
|
46.2%
6/13
|
22.2%
2/9
|
|
Psychiatric disorders
Hallucinations
|
7.7%
1/13
|
0.00%
0/9
|
|
Nervous system disorders
Poor quality sleep
|
38.5%
5/13
|
33.3%
3/9
|
|
General disorders
Irritability
|
46.2%
6/13
|
33.3%
3/9
|
|
Nervous system disorders
Memory Impairment
|
23.1%
3/13
|
22.2%
2/9
|
|
Psychiatric disorders
Hypokinesia
|
23.1%
3/13
|
0.00%
0/9
|
|
Psychiatric disorders
Psychomotor Hyperactivity
|
38.5%
5/13
|
22.2%
2/9
|
|
Nervous system disorders
Dysarthria
|
7.7%
1/13
|
0.00%
0/9
|
|
Psychiatric disorders
Suicidal Behavior
|
7.7%
1/13
|
0.00%
0/9
|
|
Psychiatric disorders
Suicidal Ideation
|
15.4%
2/13
|
11.1%
1/9
|
|
General disorders
Fatigue
|
30.8%
4/13
|
22.2%
2/9
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
30.8%
4/13
|
33.3%
3/9
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/13
|
11.1%
1/9
|
|
Injury, poisoning and procedural complications
Injury
|
7.7%
1/13
|
11.1%
1/9
|
|
General disorders
Pyrexia
|
15.4%
2/13
|
11.1%
1/9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place