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This is a Study to Determine the Antidepressant Effects of AZD6765

An Investigation of the Antidepressant Effects of an NMDA Antagonist in Treatment-Resistant Major Depression

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00986479
Enrollment
22
Registered
2009-09-30
Start date
2009-12-31
Completion date
2011-12-31
Last updated
2014-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Resistant Major Depressive Disorder

Keywords

Patients

Brief summary

The purpose of this study is to determine the antidepressant effects of AZD6765 compared to placebo.

Interventions

Single IV infusion of 150 mg AZD6765.

DRUGPlacebo to AZD6765

Single IV infusion of Placebo to AZD6765

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.

Secondary

MeasureTime frameDescription
The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).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.Response defined as a \>= 50% reduction from baseline in MADRS total score. 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.
Scale for Suicide Ideation (SSI) 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.Scale for Suicide Ideation (SSI) is a 19-item scale designed to quantify the intensity of current conscious suicide ideation. Each item is rated on a scale of 0 to 2 (with higher scores indicating greater suicidal ideation). The individual item scores are added together to form a total score, ranging between 0 and 38. 0 is considered the best outcome, 38 the worst.
Hamilton Anxiety Rating Scale (HAM-A) Total Score.60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing.Hamilton Anxiety Rating Scale (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. 0 is considered the best outcome, 56 the worst.
Hamilton Depression Rating Scale-17 Item (HDRS) Total Score60 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 dosingHamilton Depression Rating Scale-17 item (HDRS) is a scale that assesses depressive symptoms. HDRS consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher scores indicate more severe depression.
Visual Analogue Scale (VAS) Depressed Score60 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 dosingThe Visual Analog Scale (VAS) Depressed is a 0 to 100-mm self-administered scale where patients rate their mood between extreme sad (0-mm) and extreme happy (100-mm), with a median normal point.
The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).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.Remission defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score \<10. 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.
Brief Psychiatric Rating Scale (BPRS) 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.The Brief Psychiatric Rating Scale (BPRS) is a 18-item scale which measures symptoms and behaviors that are characteristic of schizophrenia. Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 18 items, resulting in a range of scores from 18-126. 18 is considered to be the best outcome, 126 the worst.
Beck Depression Inventory (BDI) 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.Beck Depression Inventory (BDI) is a 21-question instrument for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score is computed. Higher total scores indicate more severe depressive symptoms.
Young Mania Rating Scale (YMRS) 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.Young Mania Rating Scale (YMRS) consists of 11 items, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) or from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. 0 is considered to be the best outcome, 60 the worst.
Visual Analogue Scale (VAS) Anxious 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.The Visual Analog Scale (VAS) Anxious is a 0 to 100-mm self-administered scale where patients rate their mood between extreme sad (0-mm) and extreme happy (100-mm), with a median normal point.
Brief Psychiatric Rating Scale (BPRS) Positive 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.Brief Psychiatric Rating Scale (BPRS) Positive is a 4-item scale which measures positive symptoms of schizophrenia (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content). Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 4 items, resulting in a range of scores from 4-28.
Clinician-Administered Dissociative States Scale (CADSS) 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 dosingClinician- Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during dissociative experiences. This scale involves a 23 questions and each is rated from 0 (not at all) to 4 (extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.

Countries

United States

Participant flow

Recruitment details

A total of 27 patients were enrolled. Of these, 22 patients were randomized to either: (1) AZD6765 (150 mg) followed by placebo or (2) placebo followed by AZD6765 (150 mg) in a crossover study design. A total of 20 patients completed both treatment periods of the study.

Pre-assignment details

Screening for eligibility and washout of restricted medications.

Participants by arm

ArmCount
AZD6765 (150 mg)/ Placebo
Patients 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.
12
Placebo/AZD6765 (150 mg)
Patients 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.
10
Total22

Withdrawals & dropouts

PeriodReasonFG000FG001
Period 1Administrative reasons10
Period 1Improved mood10

Baseline characteristics

CharacteristicAZD6765 (150 mg)/ PlaceboPlacebo/AZD6765 (150 mg)Total
Age, Continuous50.7 years
STANDARD_DEVIATION 10.9
52.4 years
STANDARD_DEVIATION 10.5
51.5 years
STANDARD_DEVIATION 10.1
Sex: Female, Male
Female
7 Participants3 Participants10 Participants
Sex: Female, Male
Male
5 Participants7 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
21 / 2220 / 20
serious
Total, serious adverse events
0 / 220 / 20

Outcome results

Primary

Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.

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.

Time frame: 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.

Population: ITT population including all randomized patients who were given study treatment.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
AZD6765 (150 mg)Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.60 minutes26.881 Units on a scaleStandard Error 1.262
AZD6765 (150 mg)Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.80 minutes25.381 Units on a scaleStandard Error 1.262
AZD6765 (150 mg)Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.110 minutes25.835 Units on a scaleStandard Error 1.262
AZD6765 (150 mg)Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.230 minutes26.517 Units on a scaleStandard Error 1.262
AZD6765 (150 mg)Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.Day 127.654 Units on a scaleStandard Error 1.262
AZD6765 (150 mg)Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.Day 229.161 Units on a scaleStandard Error 1.288
AZD6765 (150 mg)Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.Day 330.732 Units on a scaleStandard Error 1.288
AZD6765 (150 mg)Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.Day 731.447 Units on a scaleStandard Error 1.288
PlaceboMontgomery-Asberg Depression Rating Scale (MADRS) Total Score.Day 731.222 Units on a scaleStandard Error 1.342
PlaceboMontgomery-Asberg Depression Rating Scale (MADRS) Total Score.60 minutes28.618 Units on a scaleStandard Error 1.314
PlaceboMontgomery-Asberg Depression Rating Scale (MADRS) Total Score.Day 129.118 Units on a scaleStandard Error 1.314
PlaceboMontgomery-Asberg Depression Rating Scale (MADRS) Total Score.80 minutes29.718 Units on a scaleStandard Error 1.314
PlaceboMontgomery-Asberg Depression Rating Scale (MADRS) Total Score.Day 330.368 Units on a scaleStandard Error 1.314
PlaceboMontgomery-Asberg Depression Rating Scale (MADRS) Total Score.110 minutes29.818 Units on a scaleStandard Error 1.314
PlaceboMontgomery-Asberg Depression Rating Scale (MADRS) Total Score.Day 231.368 Units on a scaleStandard Error 1.314
PlaceboMontgomery-Asberg Depression Rating Scale (MADRS) Total Score.230 minutes29.418 Units on a scaleStandard Error 1.314
Secondary

Beck Depression Inventory (BDI) Score.

Beck Depression Inventory (BDI) is a 21-question instrument for measuring the severity of depression. Each question has a set of at least four possible answer choices, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score is computed. Higher total scores indicate more severe depressive symptoms.

Time frame: 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.

Population: ITT population including all randomized patients who were given study treatment.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
AZD6765 (150 mg)Beck Depression Inventory (BDI) Score.60 minutes21.081 Units on a scaleStandard Error 2.524
AZD6765 (150 mg)Beck Depression Inventory (BDI) Score.80 minutes22.217 Units on a scaleStandard Error 2.524
AZD6765 (150 mg)Beck Depression Inventory (BDI) Score.110 minutes21.535 Units on a scaleStandard Error 2.524
AZD6765 (150 mg)Beck Depression Inventory (BDI) Score.230 minutes21.126 Units on a scaleStandard Error 2.524
AZD6765 (150 mg)Beck Depression Inventory (BDI) Score.Day 122.444 Units on a scaleStandard Error 2.524
AZD6765 (150 mg)Beck Depression Inventory (BDI) Score.Day 222.923 Units on a scaleStandard Error 2.531
AZD6765 (150 mg)Beck Depression Inventory (BDI) Score.Day 323.494 Units on a scaleStandard Error 2.531
AZD6765 (150 mg)Beck Depression Inventory (BDI) Score.Day 724.447 Units on a scaleStandard Error 2.531
PlaceboBeck Depression Inventory (BDI) Score.Day 724.070 Units on a scaleStandard Error 2.546
PlaceboBeck Depression Inventory (BDI) Score.60 minutes22.886 Units on a scaleStandard Error 2.538
PlaceboBeck Depression Inventory (BDI) Score.Day 122.936 Units on a scaleStandard Error 2.538
PlaceboBeck Depression Inventory (BDI) Score.80 minutes23.122 Units on a scaleStandard Error 2.546
PlaceboBeck Depression Inventory (BDI) Score.Day 323.786 Units on a scaleStandard Error 2.538
PlaceboBeck Depression Inventory (BDI) Score.110 minutes23.586 Units on a scaleStandard Error 2.538
PlaceboBeck Depression Inventory (BDI) Score.Day 224.586 Units on a scaleStandard Error 2.538
PlaceboBeck Depression Inventory (BDI) Score.230 minutes23.686 Units on a scaleStandard Error 2.538
Secondary

Brief Psychiatric Rating Scale (BPRS) Positive Score.

Brief Psychiatric Rating Scale (BPRS) Positive is a 4-item scale which measures positive symptoms of schizophrenia (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content). Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 4 items, resulting in a range of scores from 4-28.

Time frame: 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.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Positive Score.60 minutes9.433 Units on a scaleStandard Error 0.264
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Positive Score.80 minutes8.751 Units on a scaleStandard Error 0.264
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Positive Score.110 minutes8.660 Units on a scaleStandard Error 0.264
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Positive Score.230 minutes8.751 Units on a scaleStandard Error 0.264
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Positive Score.Day 19.114 Units on a scaleStandard Error 0.264
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Positive Score.Day 29.118 Units on a scaleStandard Error 0.269
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Positive Score.Day 39.118 Units on a scaleStandard Error 0.269
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Positive Score.Day 79.356 Units on a scaleStandard Error 0.269
PlaceboBrief Psychiatric Rating Scale (BPRS) Positive Score.Day 79.338 Units on a scaleStandard Error 0.279
PlaceboBrief Psychiatric Rating Scale (BPRS) Positive Score.60 minutes8.946 Units on a scaleStandard Error 0.274
PlaceboBrief Psychiatric Rating Scale (BPRS) Positive Score.Day 19.296 Units on a scaleStandard Error 0.274
PlaceboBrief Psychiatric Rating Scale (BPRS) Positive Score.80 minutes8.996 Units on a scaleStandard Error 0.274
PlaceboBrief Psychiatric Rating Scale (BPRS) Positive Score.Day 39.446 Units on a scaleStandard Error 0.274
PlaceboBrief Psychiatric Rating Scale (BPRS) Positive Score.110 minutes8.996 Units on a scaleStandard Error 0.274
PlaceboBrief Psychiatric Rating Scale (BPRS) Positive Score.Day 29.296 Units on a scaleStandard Error 0.274
PlaceboBrief Psychiatric Rating Scale (BPRS) Positive Score.230 minutes8.666 Units on a scaleStandard Error 0.279
Secondary

Brief Psychiatric Rating Scale (BPRS) Score.

The Brief Psychiatric Rating Scale (BPRS) is a 18-item scale which measures symptoms and behaviors that are characteristic of schizophrenia. Each item is rated from 1 to 7 with higher score indicating greater severity. The total score is the sum of the 18 items, resulting in a range of scores from 18-126. 18 is considered to be the best outcome, 126 the worst.

Time frame: 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.

Population: ITT population including all randomized patients who were given study treatment.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Score.60 minutes32.191 Units on a scaleStandard Error 1.271
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Score.80 minutes30.237 Units on a scaleStandard Error 1.271
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Score.110 minutes30.555 Units on a scaleStandard Error 1.271
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Score.230 minutes30.737 Units on a scaleStandard Error 1.271
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Score.Day 133.418 Units on a scaleStandard Error 1.271
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Score.Day 232.882 Units on a scaleStandard Error 1.291
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Score.Day 334.168 Units on a scaleStandard Error 1.291
AZD6765 (150 mg)Brief Psychiatric Rating Scale (BPRS) Score.Day 735.739 Units on a scaleStandard Error 1.291
PlaceboBrief Psychiatric Rating Scale (BPRS) Score.Day 734.428 Units on a scaleStandard Error 1.335
PlaceboBrief Psychiatric Rating Scale (BPRS) Score.60 minutes32.896 Units on a scaleStandard Error 1.314
PlaceboBrief Psychiatric Rating Scale (BPRS) Score.Day 133.596 Units on a scaleStandard Error 1.314
PlaceboBrief Psychiatric Rating Scale (BPRS) Score.80 minutes33.496 Units on a scaleStandard Error 1.314
PlaceboBrief Psychiatric Rating Scale (BPRS) Score.Day 333.046 Units on a scaleStandard Error 1.314
PlaceboBrief Psychiatric Rating Scale (BPRS) Score.110 minutes33.696 Units on a scaleStandard Error 1.314
PlaceboBrief Psychiatric Rating Scale (BPRS) Score.Day 234.496 Units on a scaleStandard Error 1.314
PlaceboBrief Psychiatric Rating Scale (BPRS) Score.230 minutes31.772 Units on a scaleStandard Error 1.314
Secondary

Clinician-Administered Dissociative States Scale (CADSS) Score.

Clinician- Administered Dissociative States Scale (CADSS) is a clinician-administered measure of perceptual, behavioral, and attentional alterations occurring during dissociative experiences. This scale involves a 23 questions and each is rated from 0 (not at all) to 4 (extremely). The total score is sum of the 23 items and range from 0 to 92 - best is 0 and worst is 92.

Time frame: 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

Population: ITT population including all randomized patients who were given study treatment.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
AZD6765 (150 mg)Clinician-Administered Dissociative States Scale (CADSS) Score.60 minutes4.104 Units on a scaleStandard Error 0.9
AZD6765 (150 mg)Clinician-Administered Dissociative States Scale (CADSS) Score.80 minutes3.324 Units on a scaleStandard Error 0.909
AZD6765 (150 mg)Clinician-Administered Dissociative States Scale (CADSS) Score.110 minutes2.831 Units on a scaleStandard Error 0.9
AZD6765 (150 mg)Clinician-Administered Dissociative States Scale (CADSS) Score.230 minutes1.240 Units on a scaleStandard Error 0.9
AZD6765 (150 mg)Clinician-Administered Dissociative States Scale (CADSS) Score.Day 11.013 Units on a scaleStandard Error 0.9
AZD6765 (150 mg)Clinician-Administered Dissociative States Scale (CADSS) Score.Day 21.360 Units on a scaleStandard Error 0.91
AZD6765 (150 mg)Clinician-Administered Dissociative States Scale (CADSS) Score.Day 31.456 Units on a scaleStandard Error 0.91
AZD6765 (150 mg)Clinician-Administered Dissociative States Scale (CADSS) Score.Day 71.313 Units on a scaleStandard Error 0.91
PlaceboClinician-Administered Dissociative States Scale (CADSS) Score.Day 71.212 Units on a scaleStandard Error 0.932
PlaceboClinician-Administered Dissociative States Scale (CADSS) Score.60 minutes1.997 Units on a scaleStandard Error 0.921
PlaceboClinician-Administered Dissociative States Scale (CADSS) Score.Day 11.147 Units on a scaleStandard Error 0.921
PlaceboClinician-Administered Dissociative States Scale (CADSS) Score.80 minutes2.297 Units on a scaleStandard Error 0.921
PlaceboClinician-Administered Dissociative States Scale (CADSS) Score.Day 31.447 Units on a scaleStandard Error 0.921
PlaceboClinician-Administered Dissociative States Scale (CADSS) Score.110 minutes2.047 Units on a scaleStandard Error 0.921
PlaceboClinician-Administered Dissociative States Scale (CADSS) Score.Day 21.397 Units on a scaleStandard Error 0.921
PlaceboClinician-Administered Dissociative States Scale (CADSS) Score.230 minutes1.497 Units on a scaleStandard Error 0.921
Secondary

Hamilton Anxiety Rating Scale (HAM-A) Total Score.

Hamilton Anxiety Rating Scale (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56. 0 is considered the best outcome, 56 the worst.

Time frame: 60 minutes (min) prior to dosing (baseline); and 230 min, 1 day, 2 days, 3 days and 7 days following dosing.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
AZD6765 (150 mg)Hamilton Anxiety Rating Scale (HAM-A) Total Score.Day 116.666 Units on a scaleStandard Error 1.181
AZD6765 (150 mg)Hamilton Anxiety Rating Scale (HAM-A) Total Score.Day 317.055 Units on a scaleStandard Error 1.19
AZD6765 (150 mg)Hamilton Anxiety Rating Scale (HAM-A) Total Score.Day 216.817 Units on a scaleStandard Error 1.19
AZD6765 (150 mg)Hamilton Anxiety Rating Scale (HAM-A) Total Score.Day 718.817 Units on a scaleStandard Error 1.19
AZD6765 (150 mg)Hamilton Anxiety Rating Scale (HAM-A) Total Score.230 minutes16.211 Units on a scaleStandard Error 1.181
PlaceboHamilton Anxiety Rating Scale (HAM-A) Total Score.Day 719.631 Units on a scaleStandard Error 1.207
PlaceboHamilton Anxiety Rating Scale (HAM-A) Total Score.230 minutes17.160 Units on a scaleStandard Error 1.207
PlaceboHamilton Anxiety Rating Scale (HAM-A) Total Score.Day 117.675 Units on a scaleStandard Error 1.198
PlaceboHamilton Anxiety Rating Scale (HAM-A) Total Score.Day 218.125 Units on a scaleStandard Error 1.198
PlaceboHamilton Anxiety Rating Scale (HAM-A) Total Score.Day 318.525 Units on a scaleStandard Error 1.198
Secondary

Hamilton Depression Rating Scale-17 Item (HDRS) Total Score

Hamilton Depression Rating Scale-17 item (HDRS) is a scale that assesses depressive symptoms. HDRS consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher scores indicate more severe depression.

Time frame: 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

Population: ITT population including all randomized patients who were given study treatment.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
AZD6765 (150 mg)Hamilton Depression Rating Scale-17 Item (HDRS) Total Score60 minutes15.930 Units on a scaleStandard Error 0.977
AZD6765 (150 mg)Hamilton Depression Rating Scale-17 Item (HDRS) Total Score80 minutes14.975 Units on a scaleStandard Error 0.977
AZD6765 (150 mg)Hamilton Depression Rating Scale-17 Item (HDRS) Total Score110 minutes15.475 Units on a scaleStandard Error 0.977
AZD6765 (150 mg)Hamilton Depression Rating Scale-17 Item (HDRS) Total Score230 minutes16.112 Units on a scaleStandard Error 0.977
AZD6765 (150 mg)Hamilton Depression Rating Scale-17 Item (HDRS) Total ScoreDay 116.748 Units on a scaleStandard Error 0.977
AZD6765 (150 mg)Hamilton Depression Rating Scale-17 Item (HDRS) Total ScoreDay 216.732 Units on a scaleStandard Error 0.977
AZD6765 (150 mg)Hamilton Depression Rating Scale-17 Item (HDRS) Total ScoreDay 317.732 Units on a scaleStandard Error 0.977
AZD6765 (150 mg)Hamilton Depression Rating Scale-17 Item (HDRS) Total ScoreDay 718.160 Units on a scaleStandard Error 0.991
PlaceboHamilton Depression Rating Scale-17 Item (HDRS) Total ScoreDay 719.438 Units on a scaleStandard Error 1.024
PlaceboHamilton Depression Rating Scale-17 Item (HDRS) Total Score60 minutes17.389 Units on a scaleStandard Error 1.008
PlaceboHamilton Depression Rating Scale-17 Item (HDRS) Total ScoreDay 117.639 Units on a scaleStandard Error 1.008
PlaceboHamilton Depression Rating Scale-17 Item (HDRS) Total Score80 minutes17.739 Units on a scaleStandard Error 1.008
PlaceboHamilton Depression Rating Scale-17 Item (HDRS) Total ScoreDay 319.039 Units on a scaleStandard Error 1.008
PlaceboHamilton Depression Rating Scale-17 Item (HDRS) Total Score110 minutes18.039 Units on a scaleStandard Error 1.008
PlaceboHamilton Depression Rating Scale-17 Item (HDRS) Total ScoreDay 219.289 Units on a scaleStandard Error 1.008
PlaceboHamilton Depression Rating Scale-17 Item (HDRS) Total Score230 minutes17.339 Units on a scaleStandard Error 1.008
Secondary

Scale for Suicide Ideation (SSI) Total Score.

Scale for Suicide Ideation (SSI) is a 19-item scale designed to quantify the intensity of current conscious suicide ideation. Each item is rated on a scale of 0 to 2 (with higher scores indicating greater suicidal ideation). The individual item scores are added together to form a total score, ranging between 0 and 38. 0 is considered the best outcome, 38 the worst.

Time frame: 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.

Population: ITT population including all randomized patients who were given study treatment.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
AZD6765 (150 mg)Scale for Suicide Ideation (SSI) Total Score.60 minutes0.955 Units on a scaleStandard Error 0.326
AZD6765 (150 mg)Scale for Suicide Ideation (SSI) Total Score.80 minutes1.137 Units on a scaleStandard Error 0.326
AZD6765 (150 mg)Scale for Suicide Ideation (SSI) Total Score.110 minutes1.137 Units on a scaleStandard Error 0.326
AZD6765 (150 mg)Scale for Suicide Ideation (SSI) Total Score.230 minutes0.864 Units on a scaleStandard Error 0.326
AZD6765 (150 mg)Scale for Suicide Ideation (SSI) Total Score.Day 11.364 Units on a scaleStandard Error 0.326
AZD6765 (150 mg)Scale for Suicide Ideation (SSI) Total Score.Day 21.236 Units on a scaleStandard Error 0.328
AZD6765 (150 mg)Scale for Suicide Ideation (SSI) Total Score.Day 31.379 Units on a scaleStandard Error 0.328
AZD6765 (150 mg)Scale for Suicide Ideation (SSI) Total Score.Day 71.379 Units on a scaleStandard Error 0.328
PlaceboScale for Suicide Ideation (SSI) Total Score.Day 71.507 Units on a scaleStandard Error 0.332
PlaceboScale for Suicide Ideation (SSI) Total Score.60 minutes0.939 Units on a scaleStandard Error 0.33
PlaceboScale for Suicide Ideation (SSI) Total Score.Day 11.539 Units on a scaleStandard Error 0.33
PlaceboScale for Suicide Ideation (SSI) Total Score.80 minutes1.039 Units on a scaleStandard Error 0.33
PlaceboScale for Suicide Ideation (SSI) Total Score.Day 31.226 Units on a scaleStandard Error 0.332
PlaceboScale for Suicide Ideation (SSI) Total Score.110 minutes0.989 Units on a scaleStandard Error 0.33
PlaceboScale for Suicide Ideation (SSI) Total Score.Day 21.189 Units on a scaleStandard Error 0.33
PlaceboScale for Suicide Ideation (SSI) Total Score.230 minutes0.939 Units on a scaleStandard Error 0.33
Secondary

The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).

Response defined as a \>= 50% reduction from baseline in MADRS total score. 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.

Time frame: 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.

Population: ITT population including all randomized patients who were given study treatment.

ArmMeasureGroupValue (NUMBER)
AZD6765 (150 mg)The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).60 minutes5 Participants
AZD6765 (150 mg)The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).80 minutes6 Participants
AZD6765 (150 mg)The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).110 minutes4 Participants
AZD6765 (150 mg)The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).230 minutes4 Participants
AZD6765 (150 mg)The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).Day 13 Participants
AZD6765 (150 mg)The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).Day 21 Participants
AZD6765 (150 mg)The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).Day 31 Participants
AZD6765 (150 mg)The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).Day 71 Participants
PlaceboThe Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).Day 70 Participants
PlaceboThe Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).60 minutes3 Participants
PlaceboThe Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).Day 10 Participants
PlaceboThe Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).80 minutes1 Participants
PlaceboThe Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).Day 30 Participants
PlaceboThe Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).110 minutes0 Participants
PlaceboThe Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).Day 20 Participants
PlaceboThe Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).230 minutes1 Participants
Secondary

The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).

Remission defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score \<10. 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.

Time frame: 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.

Population: ITT population including all randomized patients who were given study treatment.

ArmMeasureGroupValue (NUMBER)
AZD6765 (150 mg)The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).60 minutes2 Participants
AZD6765 (150 mg)The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).80 minutes4 Participants
AZD6765 (150 mg)The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).110 minutes4 Participants
AZD6765 (150 mg)The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).230 minutes2 Participants
AZD6765 (150 mg)The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).Day 12 Participants
AZD6765 (150 mg)The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).Day 21 Participants
AZD6765 (150 mg)The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).Day 31 Participants
AZD6765 (150 mg)The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).Day 71 Participants
PlaceboThe Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).Day 70 Participants
PlaceboThe Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).60 minutes1 Participants
PlaceboThe Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).Day 10 Participants
PlaceboThe Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).80 minutes0 Participants
PlaceboThe Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).Day 30 Participants
PlaceboThe Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).110 minutes0 Participants
PlaceboThe Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).Day 20 Participants
PlaceboThe Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).230 minutes0 Participants
Secondary

Visual Analogue Scale (VAS) Anxious Score.

The Visual Analog Scale (VAS) Anxious is a 0 to 100-mm self-administered scale where patients rate their mood between extreme sad (0-mm) and extreme happy (100-mm), with a median normal point.

Time frame: 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.

Population: ITT population including all randomized patients who were given study treatment.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
AZD6765 (150 mg)Visual Analogue Scale (VAS) Anxious Score.60 minutes43.898 Units on a scaleStandard Error 7.415
AZD6765 (150 mg)Visual Analogue Scale (VAS) Anxious Score.Day 144.989 Units on a scaleStandard Error 7.415
AZD6765 (150 mg)Visual Analogue Scale (VAS) Anxious Score.110 minutes42.853 Units on a scaleStandard Error 7.415
AZD6765 (150 mg)Visual Analogue Scale (VAS) Anxious Score.Day 244.718 Units on a scaleStandard Error 7.447
AZD6765 (150 mg)Visual Analogue Scale (VAS) Anxious Score.80 minutes44.216 Units on a scaleStandard Error 7.415
AZD6765 (150 mg)Visual Analogue Scale (VAS) Anxious Score.230 minutes44.580 Units on a scaleStandard Error 7.415
AZD6765 (150 mg)Visual Analogue Scale (VAS) Anxious Score.Day 750.147 Units on a scaleStandard Error 7.447
AZD6765 (150 mg)Visual Analogue Scale (VAS) Anxious Score.Day 342.623 Units on a scaleStandard Error 7.447
PlaceboVisual Analogue Scale (VAS) Anxious Score.Day 756.595 Units on a scaleStandard Error 7.551
PlaceboVisual Analogue Scale (VAS) Anxious Score.60 minutes41.929 Units on a scaleStandard Error 7.479
PlaceboVisual Analogue Scale (VAS) Anxious Score.80 minutes44.079 Units on a scaleStandard Error 7.479
PlaceboVisual Analogue Scale (VAS) Anxious Score.110 minutes44.729 Units on a scaleStandard Error 7.479
PlaceboVisual Analogue Scale (VAS) Anxious Score.230 minutes46.029 Units on a scaleStandard Error 7.479
PlaceboVisual Analogue Scale (VAS) Anxious Score.Day 147.229 Units on a scaleStandard Error 7.479
PlaceboVisual Analogue Scale (VAS) Anxious Score.Day 250.479 Units on a scaleStandard Error 7.479
PlaceboVisual Analogue Scale (VAS) Anxious Score.Day 348.279 Units on a scaleStandard Error 7.479
Secondary

Visual Analogue Scale (VAS) Depressed Score

The Visual Analog Scale (VAS) Depressed is a 0 to 100-mm self-administered scale where patients rate their mood between extreme sad (0-mm) and extreme happy (100-mm), with a median normal point.

Time frame: 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

Population: ITT population including all randomized patients who were given study treatment.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
AZD6765 (150 mg)Visual Analogue Scale (VAS) Depressed Score60 minutes55.614 Scores on a scaleStandard Error 6.137
AZD6765 (150 mg)Visual Analogue Scale (VAS) Depressed Score80 minutes58.614 Scores on a scaleStandard Error 6.137
AZD6765 (150 mg)Visual Analogue Scale (VAS) Depressed Score110 minutes60.750 Scores on a scaleStandard Error 6.137
AZD6765 (150 mg)Visual Analogue Scale (VAS) Depressed Score230 minutes55.614 Scores on a scaleStandard Error 6.137
AZD6765 (150 mg)Visual Analogue Scale (VAS) Depressed ScoreDay 162.160 Scores on a scaleStandard Error 6.137
AZD6765 (150 mg)Visual Analogue Scale (VAS) Depressed ScoreDay 265.753 Scores on a scaleStandard Error 6.166
AZD6765 (150 mg)Visual Analogue Scale (VAS) Depressed ScoreDay 366.896 Scores on a scaleStandard Error 6.166
AZD6765 (150 mg)Visual Analogue Scale (VAS) Depressed ScoreDay 768.467 Scores on a scaleStandard Error 6.166
PlaceboVisual Analogue Scale (VAS) Depressed ScoreDay 765.576 Scores on a scaleStandard Error 6.264
PlaceboVisual Analogue Scale (VAS) Depressed Score60 minutes60.562 Scores on a scaleStandard Error 6.197
PlaceboVisual Analogue Scale (VAS) Depressed ScoreDay 164.762 Scores on a scaleStandard Error 6.197
PlaceboVisual Analogue Scale (VAS) Depressed Score80 minutes57.662 Scores on a scaleStandard Error 6.197
PlaceboVisual Analogue Scale (VAS) Depressed ScoreDay 363.312 Scores on a scaleStandard Error 6.197
PlaceboVisual Analogue Scale (VAS) Depressed Score110 minutes59.062 Scores on a scaleStandard Error 6.197
PlaceboVisual Analogue Scale (VAS) Depressed ScoreDay 263.262 Scores on a scaleStandard Error 6.197
PlaceboVisual Analogue Scale (VAS) Depressed Score230 minutes61.212 Scores on a scaleStandard Error 6.197
Secondary

Young Mania Rating Scale (YMRS) Score.

Young Mania Rating Scale (YMRS) consists of 11 items, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe) or from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. 0 is considered to be the best outcome, 60 the worst.

Time frame: 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.

Population: ITT population including all randomized patients who were given study treatment.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
AZD6765 (150 mg)Young Mania Rating Scale (YMRS) Score.60 minutes4.294 Units on a scaleStandard Error 0.412
AZD6765 (150 mg)Young Mania Rating Scale (YMRS) Score.80 minutes3.748 Units on a scaleStandard Error 0.412
AZD6765 (150 mg)Young Mania Rating Scale (YMRS) Score.110 minutes3.475 Units on a scaleStandard Error 0.412
AZD6765 (150 mg)Young Mania Rating Scale (YMRS) Score.230 minutes3.748 Units on a scaleStandard Error 0.412
AZD6765 (150 mg)Young Mania Rating Scale (YMRS) Score.Day 13.748 Units on a scaleStandard Error 0.412
AZD6765 (150 mg)Young Mania Rating Scale (YMRS) Score.Day 23.699 Units on a scaleStandard Error 0.419
AZD6765 (150 mg)Young Mania Rating Scale (YMRS) Score.Day 34.270 Units on a scaleStandard Error 0.419
AZD6765 (150 mg)Young Mania Rating Scale (YMRS) Score.Day 74.366 Units on a scaleStandard Error 0.419
PlaceboYoung Mania Rating Scale (YMRS) Score.Day 74.339 Units on a scaleStandard Error 0.435
PlaceboYoung Mania Rating Scale (YMRS) Score.60 minutes3.626 Units on a scaleStandard Error 0.427
PlaceboYoung Mania Rating Scale (YMRS) Score.Day 13.326 Units on a scaleStandard Error 0.427
PlaceboYoung Mania Rating Scale (YMRS) Score.80 minutes3.526 Units on a scaleStandard Error 0.427
PlaceboYoung Mania Rating Scale (YMRS) Score.Day 33.476 Units on a scaleStandard Error 0.427
PlaceboYoung Mania Rating Scale (YMRS) Score.110 minutes3.526 Units on a scaleStandard Error 0.427
PlaceboYoung Mania Rating Scale (YMRS) Score.Day 23.676 Units on a scaleStandard Error 0.427
PlaceboYoung Mania Rating Scale (YMRS) Score.230 minutes3.526 Units on a scaleStandard Error 0.427

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026