Phase 2
N=22
This is a Study to Determine the Antidepressant Effects of AZD6765
Treatment Resistant Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00986479 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. — 26.881; 28.618; 25.381; 29.718 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD6765 (Drug); Placebo to AZD6765 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. |
26.881; 28.618; 25.381; 29.718; 25.835; 29.818 | — |
| SECONDARY The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). |
2; 1; 4; 0; 4; 0 | — |
| SECONDARY The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response). |
5; 3; 6; 1; 4; 0 | — |
| SECONDARY Scale for Suicide Ideation (SSI) Total Score. |
0.955; 0.939; 1.137; 1.039; 1.137; 0.989 | — |
| SECONDARY Hamilton Anxiety Rating Scale (HAM-A) Total Score. |
16.211; 17.160; 16.666; 17.675; 16.817; 18.125 | — |
| SECONDARY Hamilton Depression Rating Scale-17 Item (HDRS) Total Score |
15.930; 17.389; 14.975; 17.739; 15.475; 18.039 | — |
| SECONDARY Visual Analogue Scale (VAS) Depressed Score |
55.614; 60.562; 58.614; 57.662; 60.750; 59.062 | — |
| SECONDARY Clinician-Administered Dissociative States Scale (CADSS) Score. |
4.104; 1.997; 3.324; 2.297; 2.831; 2.047 | — |
| SECONDARY Brief Psychiatric Rating Scale (BPRS) Score. |
32.191; 32.896; 30.237; 33.496; 30.555; 33.696 | — |
| SECONDARY Beck Depression Inventory (BDI) Score. |
21.081; 22.886; 22.217; 23.122; 21.535; 23.586 | — |
| SECONDARY Young Mania Rating Scale (YMRS) Score. |
4.294; 3.626; 3.748; 3.526; 3.475; 3.526 | — |
| SECONDARY Visual Analogue Scale (VAS) Anxious Score. |
43.898; 41.929; 44.216; 44.079; 42.853; 44.729 | — |
| SECONDARY Brief Psychiatric Rating Scale (BPRS) Positive Score. |
9.433; 8.946; 8.751; 8.996; 8.660; 8.996 | — |
Summary
The purpose of this study is to determine the antidepressant effects of AZD6765 compared to placebo.
Eligibility Criteria
Inclusion Criteria
- Patients with a diagnosis of Major Depressive Disorder, currently depressed without psychotic features
- Females must be of non-childbearing potential.
Exclusion Criteria
- Treatment with Clozapine or ECT within 3 months prior to study
- Current or past history of psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV
Data sourced from ClinicalTrials.gov (NCT00986479). 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.