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AZD6765

Phase 2

Depression | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Apr 11, 2017

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment162

FDA Designations

No designations recorded

Clinical trial landscape

AZD6765 · 8 trials · 4 indications

Phase 2 4Phase 1 4
NCT01482221A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive DisorderMajor Depressive Disorder
COMPLETED542 Analytics
NCT00986479This is a Study to Determine the Antidepressant Effects of AZD6765Treatment Resistant Major Depressive Disorder
COMPLETED22 Analytics
NCT00781742AZD6765 Severe Major Depressive Disorder (MDD) IVMajor Depressive Disorder
COMPLETED152 Analytics
NCT00491686AZD6765 for Treatment Resistant DepressionDepression
COMPLETED34 Analytics
PHASE2COMPLETED
A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder
Major Depressive DisorderUnlock trial analytics
PHASE2COMPLETED
This is a Study to Determine the Antidepressant Effects of AZD6765
Treatment Resistant Major Depressive DisorderUnlock trial analytics
PHASE2COMPLETED
AZD6765 Severe Major Depressive Disorder (MDD) IV
Major Depressive DisorderUnlock trial analytics
PHASE2COMPLETED
AZD6765 for Treatment Resistant Depression
DepressionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Baseline to Week 6

A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.

Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
60 minutes (min) prior to dosing (baseline); and 60 min, 80 min, 110 min, 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item instrument used for the evaluation of depressive symptoms. Each item is rated on a scale of 0 to 6 (with higher scores indicating more severe depression). The individual item scores are added together to form a total score, ranging between 0 and 60. 0 is considered the best score, 60 the worst.

To give evidence of an antidepressant effect versus placebo, given together with another antidepressant confirmed by change in the MADRS total score
Baseline to week 3
The primary objective is to determine whether an antidepressant effect can be achieved in patients with Treatment Resistant Depression determined by a change from baseline in the MADRS total score.
Change from Baseline
The change in distribution, metabolism, and elimination of AZD6765 and total radioactivity after single-dose (150 mg) intravenous administration of [14C]-labelled AZD6765
Blood samples will be taken from predose until upto 240 hrs from start of infusion to assess radioactivity
The change in excretion of 14C (mass balance) in urine and faeces after a single intravenous dose of 150 mg [14C] AZD6765
Urine and feacal samples will be taken from predose until up to 240 hrs from start of infusion to assess radioactivity
Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations
on Day -1 and Day 6
Measurements of BOLD signal in the brain area BA25
Day1 (at infusion)
Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments
During the study

Secondary Endpoints

Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Baseline to Week 12
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)
Week 6 to Week 12
Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 6
Baseline to Week 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
AZD6765 (150 mg) / PlaceboEXPERIMENTALPatients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
Placebo / AZD6765 (150 mg)PLACEBO_COMPARATORPatients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
150 mg [14C] AZD6765EXPERIMENTAL -

Interventions

NameTypeDescription
AZD6765 ivDRUG50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion.
PlaceboDRUG0.9 sodium chloride \[normal saline\] solution for injection by iv infusion
AZD6765DRUGSingle IV infusion of 150 mg AZD6765.
Placebo to AZD6765DRUGSingle IV infusion of Placebo to AZD6765
150 mg [14C] AZD6765RADIATION -
midazolamDRUG -
KetamineDRUGsingle infusion
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites44

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 ...

Countries:United StatesChileSlovakiaSouth AfricaUnited Kingdom
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Frequently asked questions about AZD6765

What is AZD6765 used for?

AZD6765 is an investigational small molecule being studied for the treatment of depression, including major depressive disorder and treatment resistant major depressive disorder. It has been evaluated in clinical trials for these psychiatric conditions.

Who makes AZD6765?

AZD6765 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN.

What phase is AZD6765 in?

AZD6765 has completed Phase 2 clinical trials for depression and treatment resistant major depressive disorder. It remains an investigational drug and is not approved by regulatory authorities.

What clinical trials has AZD6765 been in?

AZD6765 has been studied in several completed trials, including NCT00491686 for treatment resistant depression, NCT00986479 for treatment resistant major depressive disorder, NCT01046630 for depression using pharmaco MRI, and NCT01217645 for drug metabolism and excretion.

Is AZD6765 the same as any other drug?

AZD6765 is also known by the chemical name [14C]AZD6765 in a study assessing its distribution, metabolism, and excretion after a single-dose intravenous administration.