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

History of Changes

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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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 ]

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2. Primary:

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

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3. Secondary:

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

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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 ]

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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 ]

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Serious Adverse Events

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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%)

More Information

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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.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00759395 History of Changes
Obsolete Identifiers:	NCT00738270
Other Study ID Numbers:	D0880C00021
Study First Received:	September 24, 2008
Results First Received:	October 10, 2012
Last Updated:	October 10, 2012
Health Authority:	United States: Institutional Review Board

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