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This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD2327 | Experimental | AZD2327 3mg BID |
|
| Placebo | Placebo Comparator | Placebo BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2327 | Drug | Tablet, Oral, Daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression (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. | Week 4 |
| Hamilton Rating Scale for Anxiety (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. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Smith, MD | AstraZeneca | Study Director |
| Carlos Zarate | National Institute of Mental Health (NIMH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26728893 | Derived | 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. |
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Screening for eligibility and wash-out of restricted medications.
A single site, randomized, double blind, placebo-controlled, parallel group experimental study. Patients recruited between November 2008 and October 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD2327 | AZD2327 3mg BID Tablet, Oral, Daily |
| FG001 | Placebo | Placebo BID, Tablet, Oral, Daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD2327 | AZD2327 3mg BID Tablet, Oral, Daily |
| BG001 | Placebo | Placebo BID, Tablet, Oral, Daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hamilton Rating Scale for Depression (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. | Posted | Least Squares Mean | Standard Error | Units on a scale | Week 4 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD2327 | AZD2327 3mg BID Tablet, Oral, Daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| C560622 | 4-((3-aminophenyl)(4-(4-fluorobenzyl)piperazin-1-yl)methyl)-N,N-diethylbenzamide |
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| Drug |
Tablet, Oral, Daily |
|
| Week 4 |
| The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score. | 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. | Randomization to week 4 |
| The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score. | 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. | Randomization to week 4 |
| Lack of Efficacy |
|
| BG002 |
| Total |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Hamilton Rating Scale for Anxiety (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. | Posted | Least Squares Mean | Standard Error | Units on a scale | Week 4 |
|
|
|
| Secondary | Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D). | 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. | Posted | Least Squares Mean | Standard Error | Units on a scale | Week 4 |
|
|
|
| Secondary | The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score. | 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. | Posted | Number | Participants | Randomization to week 4 |
|
|
|
| Secondary | The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score. | 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. | Posted | Number | Participants | Randomization to week 4 |
|
|
|
| 1 |
| 13 |
| 13 |
| 13 |
| EG001 | Placebo | Placebo BID, Tablet, Oral, Daily | 0 | 9 | 9 | 9 |
| Tachycardia | Cardiac disorders |
|
| Chest Pain | General disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders |
|
| Hypertension | Vascular disorders |
|
| Breast pain | Reproductive system and breast disorders |
|
| Ear Pain | Ear and labyrinth disorders |
|
| Tinnitus | Ear and labyrinth disorders |
|
| Vision blurred | Eye disorders |
|
| Eye Irritation | Eye disorders |
|
| Decreased Appetite | Metabolism and nutrition disorders |
|
| Increased Appetite | Metabolism and nutrition disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Flatulence | Gastrointestinal disorders |
|
| Thirst | General disorders |
|
| Pollakiuria | Renal and urinary disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Abdominal Discomfort | Gastrointestinal disorders |
|
| Faeces discoloured | Gastrointestinal disorders |
|
| Dysgeusia | Nervous system disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Weight Increased | Investigations |
|
| Weight Decreased | Investigations |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders |
|
| Libido Decreased | Psychiatric disorders |
|
| Genital Discomfort | Reproductive system and breast disorders |
|
| Libido Increased | Psychiatric disorders |
|
| Menstruation Irregular | Reproductive system and breast disorders |
|
| Dysuria | Renal and urinary disorders |
|
| Premenstrual syndrome | Reproductive system and breast disorders |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Dental Care | Surgical and medical procedures |
|
| Dry Mouth | Gastrointestinal disorders |
|
| Gingival Disorder | Gastrointestinal disorders |
|
| Salivary Hypersecretion | Gastrointestinal disorders |
|
| Mouth Ulceration | Gastrointestinal disorders |
|
| Akathisia | Nervous system disorders |
|
| Dyskinesia | Nervous system disorders |
|
| Oedema | General disorders |
|
| Muscle Rigidity | Musculoskeletal and connective tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Tic | Psychiatric disorders |
|
| Tremor | Nervous system disorders |
|
| Malignant Dysphagia | Gastrointestinal disorders |
|
| Influenza | Infections and infestations |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders |
|
| Disturbance in attaention | Nervous system disorders |
|
| Confusional State | Psychiatric disorders |
|
| Depression | Psychiatric disorders |
|
| Initial Insomnia | Psychiatric disorders |
|
| Somnolence | Psychiatric disorders |
|
| Terminal Insomnia | Psychiatric disorders |
|
| Hallucinations | Psychiatric disorders |
|
| Poor quality sleep | Nervous system disorders |
|
| Irritability | General disorders |
|
| Memory Impairment | Nervous system disorders |
|
| Hypokinesia | Psychiatric disorders |
|
| Psychomotor Hyperactivity | Psychiatric disorders |
|
| Dysarthria | Nervous system disorders |
|
| Suicidal Behavior | Psychiatric disorders |
|
| Suicidal Ideation | Psychiatric disorders |
|
| Fatigue | General disorders |
|
| Skin irritation | Skin and subcutaneous tissue disorders |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders |
|
| Injury | Injury, poisoning and procedural complications |
|
| Pyrexia | General disorders |
|
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