Phase 2
N=22
Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)
Anxious Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00759395 ↗Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Nov 2012
Primary outcome: Primary: Hamilton Rating Scale for Depression (HAM-D) Total Score. — 14.249; 16.307 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD2327 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Rating Scale for Depression (HAM-D) Total Score. |
14.249; 16.307 | — |
| PRIMARY Hamilton Rating Scale for Anxiety (HAM-A) Total Score. |
13.029; 17.736 | — |
| SECONDARY Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D). |
1.373; 2.128 | — |
| SECONDARY The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score. |
5; 4 | — |
| SECONDARY The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score. |
7; 3 | — |
Summary
This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder.
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures
- Diagnosis of major depressive disorder without psychotic features (MDD)
Exclusion Criteria
- A history of substance or alcohol abuse within the past 6 months or dependence within 1 year of enrollment as defined by DSM-IV criteria.
- Women that are pregnant or lactating
- History of pancreatitis
Data sourced from ClinicalTrials.gov (NCT00759395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.