Trial Outcomes & Findings for 6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder (NCT NCT01145755)

Last Updated: 2012-10-03

Results Overview

Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

131 participants

Primary outcome timeframe

6 weeks

Results posted on

2012-10-03

Participant Flow

This study was conducted only in the United States (US). A total of 13 study centers enrolled 249 patients. First subject enrolled: 27 May 2010 Last subject last visit: 10 November 2010

Patients with major depressive disorder were included.

Participant milestones

Participant milestones
Measure	AZD2066 AZD2066 12 mg, 18 mg	Duloxetine Duloxetine 30 mg, 60 mg	Placebo Placebo
Overall Study STARTED	40	47	44
Overall Study COMPLETED	20	19	19
Overall Study NOT COMPLETED	20	28	25

Reasons for withdrawal

Reasons for withdrawal
Measure	AZD2066 AZD2066 12 mg, 18 mg	Duloxetine Duloxetine 30 mg, 60 mg	Placebo Placebo
Overall Study Adverse Event	2	4	2
Overall Study Withdrawal by Subject	0	0	1
Overall Study Lost to Follow-up	2	3	1
Overall Study Protocol Violation	0	3	1
Overall Study Study Closure	14	14	17
Overall Study Lack of Efficacy	0	1	0
Overall Study Patient could not swollow medication	0	0	1
Overall Study Positive urine ethanol	0	1	0

Baseline Characteristics

6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD2066 n=40 Participants AZD2066 12 mg, 18 mg	Duloxetine n=47 Participants Duloxetine 30 mg, 60 mg	Placebo n=44 Participants Placebo	Total n=131 Participants Total of all reporting groups
Age Continuous	42.2 Years n=93 Participants	39.9 Years n=4 Participants	38.4 Years n=27 Participants	40.1 Years n=483 Participants
Sex: Female, Male Female	23 Participants n=93 Participants	24 Participants n=4 Participants	30 Participants n=27 Participants	77 Participants n=483 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	23 Participants n=4 Participants	14 Participants n=27 Participants	54 Participants n=483 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	AZD2066 n=39 Participants AZD2066 12 mg, 18 mg	Duloxetine n=45 Participants Duloxetine 30 mg, 60 mg	Placebo n=40 Participants Placebo
MADRS Total Score Change From Baseline to Week 6	-13.1658 scores on the scale Standard Deviation 2.11	-14.0271 scores on the scale Standard Deviation 1.97	-14.1575 scores on the scale Standard Deviation 2.16

SECONDARY outcome

Timeframe: 6 weeks

A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.

Outcome measures

Outcome measures
Measure	AZD2066 n=21 Participants AZD2066 12 mg, 18 mg	Duloxetine n=20 Participants Duloxetine 30 mg, 60 mg	Placebo n=19 Participants Placebo
MADRS Response	9 Participants	9 Participants	9 Participants

SECONDARY outcome

Timeframe: 6 weeks

A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6

Outcome measures

Outcome measures
Measure	AZD2066 n=21 Participants AZD2066 12 mg, 18 mg	Duloxetine n=20 Participants Duloxetine 30 mg, 60 mg	Placebo n=19 Participants Placebo
MADRS Remission	5 Participants	8 Participants	7 Participants

Adverse Events

AZD2066

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Duloxetine

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AZD2066 n=40 participants at risk AZD2066 12 mg, 18 mg	Duloxetine n=47 participants at risk Duloxetine 30 mg, 60 mg	Placebo n=44 participants at risk Placebo
Reproductive system and breast disorders Ovarian mass	2.5% 1/40	0.00% 0/47	0.00% 0/44

Other adverse events

Other adverse events
Measure	AZD2066 n=40 participants at risk AZD2066 12 mg, 18 mg	Duloxetine n=47 participants at risk Duloxetine 30 mg, 60 mg	Placebo n=44 participants at risk Placebo
Gastrointestinal disorders NAUSEA	15.0% 6/40	25.5% 12/47	9.1% 4/44
Gastrointestinal disorders DIARRHOEA	7.5% 3/40	21.3% 10/47	9.1% 4/44
Gastrointestinal disorders DRY MOUTH	2.5% 1/40	14.9% 7/47	9.1% 4/44
Gastrointestinal disorders CONSTIPATION	10.0% 4/40	2.1% 1/47	6.8% 3/44
Gastrointestinal disorders ABDOMINAL PAIN	5.0% 2/40	0.00% 0/47	0.00% 0/44
Gastrointestinal disorders DYSPEPSIA	5.0% 2/40	0.00% 0/47	0.00% 0/44
General disorders IRRITABILITY	5.0% 2/40	0.00% 0/47	2.3% 1/44
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	10.0% 4/40	6.4% 3/47	2.3% 1/44
Metabolism and nutrition disorders INCREASED APPETITE	5.0% 2/40	0.00% 0/47	2.3% 1/44
Nervous system disorders HEADACHE	25.0% 10/40	14.9% 7/47	0.00% 0/44
Nervous system disorders SOMNOLENCE	5.0% 2/40	10.6% 5/47	0.00% 0/44
Nervous system disorders DIZZINESS	7.5% 3/40	6.4% 3/47	4.5% 2/44
Psychiatric disorders INSOMNIA	10.0% 4/40	4.3% 2/47	0.00% 0/44
Psychiatric disorders ANXIETY	5.0% 2/40	0.00% 0/47	4.5% 2/44
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.00% 0/40	10.6% 5/47	2.3% 1/44
Skin and subcutaneous tissue disorders RASH	5.0% 2/40	2.1% 1/47	0.00% 0/44

Additional Information

Gerard Lynch

AstraZeneca

Phone: 645895

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No publication or presentation of results until the earlier of 1) the date of the first study results publication or 2) 18 months after completion or termination of the study. AZ review 60 days prior submission and AZ has the possibility to further delay publication for an additional 90 days
Publication restrictions are in place

Restriction type: OTHER