Phase 2
Completed N=302
A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder
Source: ClinicalTrials.gov NCT01482221 ↗Enrolled (actual)
302
Serious AEs
3.3%
Results posted
Apr 2017
Primary outcomePrimary: Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — -14.37; -14.40; -13.18 units on a scale — p=0.630
Summary
The purpose of this study is to assess the effect and safety of AZD6765 in patients with major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a channel blocker of the N-methyl-D-aspartate (NMDA) class of glutamate receptors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-14.37; -14.40; -13.18 | 0.630 |
| SECONDARY Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-15.97; -13.03; -13.92 | 0.630 |
| SECONDARY Percentage of Patients With Sustained Response From Week 6 to Week 12 (Defined as ≥50% Reduction From Baseline in the MADRS Total Score at Week 6 and Which is Maintained Through Week 12) |
22.8; 23.0; 21.6 | 0.852 |
| SECONDARY Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 6 |
36.0; 44.0; 39.0 | 0.751 |
| SECONDARY Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 12 |
48.3; 36.5; 40.7 | 0.434 |
| SECONDARY Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 6 |
23.3; 23.8; 18.3 | 0.357 |
| SECONDARY Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 12 |
27.0; 22.4; 25.9 | 0.911 |
| SECONDARY Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score |
-7.08; -6.90; -6.91; -6.98; -6.80; -8.09 | 0.889 |
| SECONDARY Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score |
-1.5; -1.5; -1.4; -1.8; -1.5; -1.6 | 0.728 |
| SECONDARY Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of "Very Much Improved" or "Much Improved") at Week 6 |
51.2; 47.6; 37.8 | 0.067 |
| SECONDARY Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of "Very Much Improved" or "Much Improved") at Week 12 |
50.6; 44.7; 40.7 | 0.268 |
| SECONDARY Change From Baseline in Self-rated Severity of Depressive Symptoms as Measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item Scale (QIDS-SR-16) Total Score |
-8.7; -7.9; -8.1; -9.2; -7.6; -8.9 | 0.505 |
Eligibility Criteria
Inclusion Criteria
- Provision of signed and dated informed consent before initiation of any study-related procedures.
- Male or female patients aged 18 to 70 years, inclusive.
- The patient must have a clinical diagnosis of major depressive disorder with a lifetime history of inadequate response to at least 3 antidepressants.
- Women of child-bearing potential must have a negative serum pregnancy test and confirmed use of a highly effective form of birth control before enrollment for a minimum of 3 months before study start.
- Outpatient status at screening and randomization visits.
Exclusion Criteria
- Patients with a history of diagnosed bipolar disorder or schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression; dementia or suspicion thereof.
- Patients who have had a suicide attempt within the last 6 months.
- Electroconvulsive therapy (ECT), vagal nerve stimulation (VNS) or transcranial magnetic stimulation (TMS) or previous treatment with ketamine infusion within the 6 months prior to screening, or any history of deep brain stimulation.
- Patients with any history of seizure disorder (except for febrile seizures in childhood).
- Pregnancy or lactation.
Data sourced from ClinicalTrials.gov (NCT01482221). 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.