Phase 2
Completed N=247
AZD7268 Safety and Tolerability Study
Source: ClinicalTrials.gov NCT01020799 ↗Enrolled (actual)
247
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcomePrimary: Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4. — -11.78; -11.45; -11.70 scores on a scale
Summary
The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4. |
-11.78; -11.45; -11.70 | — |
| SECONDARY Montgomery-Åsberg Depression Rating Scale (MADRS) Response |
31; 31; 14 | — |
| SECONDARY Montgomery-Åsberg Depression Rating Scale (MADRS) Remission |
20; 12; 10 | — |
| SECONDARY Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4. |
-9.22; -9.15; -9.84 | — |
| SECONDARY Clinical Global Impression - Severity (CGI-S) Score Change From Baseline |
-1.26; -1.15; -1.31 | — |
| SECONDARY Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline |
-5.30; -4.66; -6.15 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of signed, written, and dated Informed Consent prior to any study specific procedures
- Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following:
- 296.2x Major Depressive Disorder, Single Episode, or
- 296.3x Major Depressive Disorder, Recurrent
Exclusion Criteria
- Patients with a secondary DSM-IV Axis I disorder other than GAD or social anxiety disorder (as assessed by MINI), provided the primary diagnosis is MDD. This diagnosis should have been made at least 6 months before enrollment
- Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
- Patients whose current episode of depression started less than 4 weeks before enrollment
Data sourced from ClinicalTrials.gov (NCT01020799). 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. Informational only — not medical advice.