Treatment Resistant Major Depressive Disorder
Conditions
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.
Single IV infusion of Placebo to AZD6765
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | 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. |
| Visual Analogue Scale (VAS) Depressed 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) 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 dosing | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Administrative reasons | 1 | 0 |
| Period 1 | Improved mood | 1 | 0 |
Baseline characteristics
| Characteristic | AZD6765 (150 mg)/ Placebo | Placebo/AZD6765 (150 mg) | Total |
|---|---|---|---|
| Age, Continuous | 50.7 years STANDARD_DEVIATION 10.9 | 52.4 years STANDARD_DEVIATION 10.5 | 51.5 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 22 | 20 / 20 |
| serious Total, serious adverse events | 0 / 22 | 0 / 20 |
Outcome results
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD6765 (150 mg) | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | 60 minutes | 26.881 Units on a scale | Standard Error 1.262 |
| AZD6765 (150 mg) | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | 80 minutes | 25.381 Units on a scale | Standard Error 1.262 |
| AZD6765 (150 mg) | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | 110 minutes | 25.835 Units on a scale | Standard Error 1.262 |
| AZD6765 (150 mg) | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | 230 minutes | 26.517 Units on a scale | Standard Error 1.262 |
| AZD6765 (150 mg) | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Day 1 | 27.654 Units on a scale | Standard Error 1.262 |
| AZD6765 (150 mg) | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Day 2 | 29.161 Units on a scale | Standard Error 1.288 |
| AZD6765 (150 mg) | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Day 3 | 30.732 Units on a scale | Standard Error 1.288 |
| AZD6765 (150 mg) | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Day 7 | 31.447 Units on a scale | Standard Error 1.288 |
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Day 7 | 31.222 Units on a scale | Standard Error 1.342 |
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | 60 minutes | 28.618 Units on a scale | Standard Error 1.314 |
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Day 1 | 29.118 Units on a scale | Standard Error 1.314 |
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | 80 minutes | 29.718 Units on a scale | Standard Error 1.314 |
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Day 3 | 30.368 Units on a scale | Standard Error 1.314 |
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | 110 minutes | 29.818 Units on a scale | Standard Error 1.314 |
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | Day 2 | 31.368 Units on a scale | Standard Error 1.314 |
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | 230 minutes | 29.418 Units on a scale | Standard Error 1.314 |
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD6765 (150 mg) | Beck Depression Inventory (BDI) Score. | 60 minutes | 21.081 Units on a scale | Standard Error 2.524 |
| AZD6765 (150 mg) | Beck Depression Inventory (BDI) Score. | 80 minutes | 22.217 Units on a scale | Standard Error 2.524 |
| AZD6765 (150 mg) | Beck Depression Inventory (BDI) Score. | 110 minutes | 21.535 Units on a scale | Standard Error 2.524 |
| AZD6765 (150 mg) | Beck Depression Inventory (BDI) Score. | 230 minutes | 21.126 Units on a scale | Standard Error 2.524 |
| AZD6765 (150 mg) | Beck Depression Inventory (BDI) Score. | Day 1 | 22.444 Units on a scale | Standard Error 2.524 |
| AZD6765 (150 mg) | Beck Depression Inventory (BDI) Score. | Day 2 | 22.923 Units on a scale | Standard Error 2.531 |
| AZD6765 (150 mg) | Beck Depression Inventory (BDI) Score. | Day 3 | 23.494 Units on a scale | Standard Error 2.531 |
| AZD6765 (150 mg) | Beck Depression Inventory (BDI) Score. | Day 7 | 24.447 Units on a scale | Standard Error 2.531 |
| Placebo | Beck Depression Inventory (BDI) Score. | Day 7 | 24.070 Units on a scale | Standard Error 2.546 |
| Placebo | Beck Depression Inventory (BDI) Score. | 60 minutes | 22.886 Units on a scale | Standard Error 2.538 |
| Placebo | Beck Depression Inventory (BDI) Score. | Day 1 | 22.936 Units on a scale | Standard Error 2.538 |
| Placebo | Beck Depression Inventory (BDI) Score. | 80 minutes | 23.122 Units on a scale | Standard Error 2.546 |
| Placebo | Beck Depression Inventory (BDI) Score. | Day 3 | 23.786 Units on a scale | Standard Error 2.538 |
| Placebo | Beck Depression Inventory (BDI) Score. | 110 minutes | 23.586 Units on a scale | Standard Error 2.538 |
| Placebo | Beck Depression Inventory (BDI) Score. | Day 2 | 24.586 Units on a scale | Standard Error 2.538 |
| Placebo | Beck Depression Inventory (BDI) Score. | 230 minutes | 23.686 Units on a scale | Standard Error 2.538 |
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Positive Score. | 60 minutes | 9.433 Units on a scale | Standard Error 0.264 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Positive Score. | 80 minutes | 8.751 Units on a scale | Standard Error 0.264 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Positive Score. | 110 minutes | 8.660 Units on a scale | Standard Error 0.264 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Positive Score. | 230 minutes | 8.751 Units on a scale | Standard Error 0.264 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Positive Score. | Day 1 | 9.114 Units on a scale | Standard Error 0.264 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Positive Score. | Day 2 | 9.118 Units on a scale | Standard Error 0.269 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Positive Score. | Day 3 | 9.118 Units on a scale | Standard Error 0.269 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Positive Score. | Day 7 | 9.356 Units on a scale | Standard Error 0.269 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Positive Score. | Day 7 | 9.338 Units on a scale | Standard Error 0.279 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Positive Score. | 60 minutes | 8.946 Units on a scale | Standard Error 0.274 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Positive Score. | Day 1 | 9.296 Units on a scale | Standard Error 0.274 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Positive Score. | 80 minutes | 8.996 Units on a scale | Standard Error 0.274 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Positive Score. | Day 3 | 9.446 Units on a scale | Standard Error 0.274 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Positive Score. | 110 minutes | 8.996 Units on a scale | Standard Error 0.274 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Positive Score. | Day 2 | 9.296 Units on a scale | Standard Error 0.274 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Positive Score. | 230 minutes | 8.666 Units on a scale | Standard Error 0.279 |
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Score. | 60 minutes | 32.191 Units on a scale | Standard Error 1.271 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Score. | 80 minutes | 30.237 Units on a scale | Standard Error 1.271 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Score. | 110 minutes | 30.555 Units on a scale | Standard Error 1.271 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Score. | 230 minutes | 30.737 Units on a scale | Standard Error 1.271 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Score. | Day 1 | 33.418 Units on a scale | Standard Error 1.271 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Score. | Day 2 | 32.882 Units on a scale | Standard Error 1.291 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Score. | Day 3 | 34.168 Units on a scale | Standard Error 1.291 |
| AZD6765 (150 mg) | Brief Psychiatric Rating Scale (BPRS) Score. | Day 7 | 35.739 Units on a scale | Standard Error 1.291 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Score. | Day 7 | 34.428 Units on a scale | Standard Error 1.335 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Score. | 60 minutes | 32.896 Units on a scale | Standard Error 1.314 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Score. | Day 1 | 33.596 Units on a scale | Standard Error 1.314 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Score. | 80 minutes | 33.496 Units on a scale | Standard Error 1.314 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Score. | Day 3 | 33.046 Units on a scale | Standard Error 1.314 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Score. | 110 minutes | 33.696 Units on a scale | Standard Error 1.314 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Score. | Day 2 | 34.496 Units on a scale | Standard Error 1.314 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) Score. | 230 minutes | 31.772 Units on a scale | Standard Error 1.314 |
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD6765 (150 mg) | Clinician-Administered Dissociative States Scale (CADSS) Score. | 60 minutes | 4.104 Units on a scale | Standard Error 0.9 |
| AZD6765 (150 mg) | Clinician-Administered Dissociative States Scale (CADSS) Score. | 80 minutes | 3.324 Units on a scale | Standard Error 0.909 |
| AZD6765 (150 mg) | Clinician-Administered Dissociative States Scale (CADSS) Score. | 110 minutes | 2.831 Units on a scale | Standard Error 0.9 |
| AZD6765 (150 mg) | Clinician-Administered Dissociative States Scale (CADSS) Score. | 230 minutes | 1.240 Units on a scale | Standard Error 0.9 |
| AZD6765 (150 mg) | Clinician-Administered Dissociative States Scale (CADSS) Score. | Day 1 | 1.013 Units on a scale | Standard Error 0.9 |
| AZD6765 (150 mg) | Clinician-Administered Dissociative States Scale (CADSS) Score. | Day 2 | 1.360 Units on a scale | Standard Error 0.91 |
| AZD6765 (150 mg) | Clinician-Administered Dissociative States Scale (CADSS) Score. | Day 3 | 1.456 Units on a scale | Standard Error 0.91 |
| AZD6765 (150 mg) | Clinician-Administered Dissociative States Scale (CADSS) Score. | Day 7 | 1.313 Units on a scale | Standard Error 0.91 |
| Placebo | Clinician-Administered Dissociative States Scale (CADSS) Score. | Day 7 | 1.212 Units on a scale | Standard Error 0.932 |
| Placebo | Clinician-Administered Dissociative States Scale (CADSS) Score. | 60 minutes | 1.997 Units on a scale | Standard Error 0.921 |
| Placebo | Clinician-Administered Dissociative States Scale (CADSS) Score. | Day 1 | 1.147 Units on a scale | Standard Error 0.921 |
| Placebo | Clinician-Administered Dissociative States Scale (CADSS) Score. | 80 minutes | 2.297 Units on a scale | Standard Error 0.921 |
| Placebo | Clinician-Administered Dissociative States Scale (CADSS) Score. | Day 3 | 1.447 Units on a scale | Standard Error 0.921 |
| Placebo | Clinician-Administered Dissociative States Scale (CADSS) Score. | 110 minutes | 2.047 Units on a scale | Standard Error 0.921 |
| Placebo | Clinician-Administered Dissociative States Scale (CADSS) Score. | Day 2 | 1.397 Units on a scale | Standard Error 0.921 |
| Placebo | Clinician-Administered Dissociative States Scale (CADSS) Score. | 230 minutes | 1.497 Units on a scale | Standard Error 0.921 |
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD6765 (150 mg) | Hamilton Anxiety Rating Scale (HAM-A) Total Score. | Day 1 | 16.666 Units on a scale | Standard Error 1.181 |
| AZD6765 (150 mg) | Hamilton Anxiety Rating Scale (HAM-A) Total Score. | Day 3 | 17.055 Units on a scale | Standard Error 1.19 |
| AZD6765 (150 mg) | Hamilton Anxiety Rating Scale (HAM-A) Total Score. | Day 2 | 16.817 Units on a scale | Standard Error 1.19 |
| AZD6765 (150 mg) | Hamilton Anxiety Rating Scale (HAM-A) Total Score. | Day 7 | 18.817 Units on a scale | Standard Error 1.19 |
| AZD6765 (150 mg) | Hamilton Anxiety Rating Scale (HAM-A) Total Score. | 230 minutes | 16.211 Units on a scale | Standard Error 1.181 |
| Placebo | Hamilton Anxiety Rating Scale (HAM-A) Total Score. | Day 7 | 19.631 Units on a scale | Standard Error 1.207 |
| Placebo | Hamilton Anxiety Rating Scale (HAM-A) Total Score. | 230 minutes | 17.160 Units on a scale | Standard Error 1.207 |
| Placebo | Hamilton Anxiety Rating Scale (HAM-A) Total Score. | Day 1 | 17.675 Units on a scale | Standard Error 1.198 |
| Placebo | Hamilton Anxiety Rating Scale (HAM-A) Total Score. | Day 2 | 18.125 Units on a scale | Standard Error 1.198 |
| Placebo | Hamilton Anxiety Rating Scale (HAM-A) Total Score. | Day 3 | 18.525 Units on a scale | Standard Error 1.198 |
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD6765 (150 mg) | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | 60 minutes | 15.930 Units on a scale | Standard Error 0.977 |
| AZD6765 (150 mg) | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | 80 minutes | 14.975 Units on a scale | Standard Error 0.977 |
| AZD6765 (150 mg) | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | 110 minutes | 15.475 Units on a scale | Standard Error 0.977 |
| AZD6765 (150 mg) | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | 230 minutes | 16.112 Units on a scale | Standard Error 0.977 |
| AZD6765 (150 mg) | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | Day 1 | 16.748 Units on a scale | Standard Error 0.977 |
| AZD6765 (150 mg) | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | Day 2 | 16.732 Units on a scale | Standard Error 0.977 |
| AZD6765 (150 mg) | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | Day 3 | 17.732 Units on a scale | Standard Error 0.977 |
| AZD6765 (150 mg) | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | Day 7 | 18.160 Units on a scale | Standard Error 0.991 |
| Placebo | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | Day 7 | 19.438 Units on a scale | Standard Error 1.024 |
| Placebo | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | 60 minutes | 17.389 Units on a scale | Standard Error 1.008 |
| Placebo | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | Day 1 | 17.639 Units on a scale | Standard Error 1.008 |
| Placebo | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | 80 minutes | 17.739 Units on a scale | Standard Error 1.008 |
| Placebo | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | Day 3 | 19.039 Units on a scale | Standard Error 1.008 |
| Placebo | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | 110 minutes | 18.039 Units on a scale | Standard Error 1.008 |
| Placebo | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | Day 2 | 19.289 Units on a scale | Standard Error 1.008 |
| Placebo | Hamilton Depression Rating Scale-17 Item (HDRS) Total Score | 230 minutes | 17.339 Units on a scale | Standard Error 1.008 |
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD6765 (150 mg) | Scale for Suicide Ideation (SSI) Total Score. | 60 minutes | 0.955 Units on a scale | Standard Error 0.326 |
| AZD6765 (150 mg) | Scale for Suicide Ideation (SSI) Total Score. | 80 minutes | 1.137 Units on a scale | Standard Error 0.326 |
| AZD6765 (150 mg) | Scale for Suicide Ideation (SSI) Total Score. | 110 minutes | 1.137 Units on a scale | Standard Error 0.326 |
| AZD6765 (150 mg) | Scale for Suicide Ideation (SSI) Total Score. | 230 minutes | 0.864 Units on a scale | Standard Error 0.326 |
| AZD6765 (150 mg) | Scale for Suicide Ideation (SSI) Total Score. | Day 1 | 1.364 Units on a scale | Standard Error 0.326 |
| AZD6765 (150 mg) | Scale for Suicide Ideation (SSI) Total Score. | Day 2 | 1.236 Units on a scale | Standard Error 0.328 |
| AZD6765 (150 mg) | Scale for Suicide Ideation (SSI) Total Score. | Day 3 | 1.379 Units on a scale | Standard Error 0.328 |
| AZD6765 (150 mg) | Scale for Suicide Ideation (SSI) Total Score. | Day 7 | 1.379 Units on a scale | Standard Error 0.328 |
| Placebo | Scale for Suicide Ideation (SSI) Total Score. | Day 7 | 1.507 Units on a scale | Standard Error 0.332 |
| Placebo | Scale for Suicide Ideation (SSI) Total Score. | 60 minutes | 0.939 Units on a scale | Standard Error 0.33 |
| Placebo | Scale for Suicide Ideation (SSI) Total Score. | Day 1 | 1.539 Units on a scale | Standard Error 0.33 |
| Placebo | Scale for Suicide Ideation (SSI) Total Score. | 80 minutes | 1.039 Units on a scale | Standard Error 0.33 |
| Placebo | Scale for Suicide Ideation (SSI) Total Score. | Day 3 | 1.226 Units on a scale | Standard Error 0.332 |
| Placebo | Scale for Suicide Ideation (SSI) Total Score. | 110 minutes | 0.989 Units on a scale | Standard Error 0.33 |
| Placebo | Scale for Suicide Ideation (SSI) Total Score. | Day 2 | 1.189 Units on a scale | Standard Error 0.33 |
| Placebo | Scale for Suicide Ideation (SSI) Total Score. | 230 minutes | 0.939 Units on a scale | Standard Error 0.33 |
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.
| Arm | Measure | Group | Value (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 minutes | 5 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 minutes | 6 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 minutes | 4 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 minutes | 4 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 1 | 3 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 2 | 1 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 3 | 1 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 7 | 1 Participants |
| Placebo | The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response). | Day 7 | 0 Participants |
| Placebo | The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response). | 60 minutes | 3 Participants |
| Placebo | The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response). | Day 1 | 0 Participants |
| Placebo | The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response). | 80 minutes | 1 Participants |
| Placebo | The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response). | Day 3 | 0 Participants |
| Placebo | The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response). | 110 minutes | 0 Participants |
| Placebo | The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response). | Day 2 | 0 Participants |
| Placebo | The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response). | 230 minutes | 1 Participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AZD6765 (150 mg) | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | 60 minutes | 2 Participants |
| AZD6765 (150 mg) | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | 80 minutes | 4 Participants |
| AZD6765 (150 mg) | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | 110 minutes | 4 Participants |
| AZD6765 (150 mg) | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | 230 minutes | 2 Participants |
| AZD6765 (150 mg) | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | Day 1 | 2 Participants |
| AZD6765 (150 mg) | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | Day 2 | 1 Participants |
| AZD6765 (150 mg) | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | Day 3 | 1 Participants |
| AZD6765 (150 mg) | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | Day 7 | 1 Participants |
| Placebo | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | Day 7 | 0 Participants |
| Placebo | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | 60 minutes | 1 Participants |
| Placebo | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | Day 1 | 0 Participants |
| Placebo | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | 80 minutes | 0 Participants |
| Placebo | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | Day 3 | 0 Participants |
| Placebo | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | 110 minutes | 0 Participants |
| Placebo | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | Day 2 | 0 Participants |
| Placebo | The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission). | 230 minutes | 0 Participants |
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Anxious Score. | 60 minutes | 43.898 Units on a scale | Standard Error 7.415 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Anxious Score. | Day 1 | 44.989 Units on a scale | Standard Error 7.415 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Anxious Score. | 110 minutes | 42.853 Units on a scale | Standard Error 7.415 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Anxious Score. | Day 2 | 44.718 Units on a scale | Standard Error 7.447 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Anxious Score. | 80 minutes | 44.216 Units on a scale | Standard Error 7.415 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Anxious Score. | 230 minutes | 44.580 Units on a scale | Standard Error 7.415 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Anxious Score. | Day 7 | 50.147 Units on a scale | Standard Error 7.447 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Anxious Score. | Day 3 | 42.623 Units on a scale | Standard Error 7.447 |
| Placebo | Visual Analogue Scale (VAS) Anxious Score. | Day 7 | 56.595 Units on a scale | Standard Error 7.551 |
| Placebo | Visual Analogue Scale (VAS) Anxious Score. | 60 minutes | 41.929 Units on a scale | Standard Error 7.479 |
| Placebo | Visual Analogue Scale (VAS) Anxious Score. | 80 minutes | 44.079 Units on a scale | Standard Error 7.479 |
| Placebo | Visual Analogue Scale (VAS) Anxious Score. | 110 minutes | 44.729 Units on a scale | Standard Error 7.479 |
| Placebo | Visual Analogue Scale (VAS) Anxious Score. | 230 minutes | 46.029 Units on a scale | Standard Error 7.479 |
| Placebo | Visual Analogue Scale (VAS) Anxious Score. | Day 1 | 47.229 Units on a scale | Standard Error 7.479 |
| Placebo | Visual Analogue Scale (VAS) Anxious Score. | Day 2 | 50.479 Units on a scale | Standard Error 7.479 |
| Placebo | Visual Analogue Scale (VAS) Anxious Score. | Day 3 | 48.279 Units on a scale | Standard Error 7.479 |
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Depressed Score | 60 minutes | 55.614 Scores on a scale | Standard Error 6.137 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Depressed Score | 80 minutes | 58.614 Scores on a scale | Standard Error 6.137 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Depressed Score | 110 minutes | 60.750 Scores on a scale | Standard Error 6.137 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Depressed Score | 230 minutes | 55.614 Scores on a scale | Standard Error 6.137 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Depressed Score | Day 1 | 62.160 Scores on a scale | Standard Error 6.137 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Depressed Score | Day 2 | 65.753 Scores on a scale | Standard Error 6.166 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Depressed Score | Day 3 | 66.896 Scores on a scale | Standard Error 6.166 |
| AZD6765 (150 mg) | Visual Analogue Scale (VAS) Depressed Score | Day 7 | 68.467 Scores on a scale | Standard Error 6.166 |
| Placebo | Visual Analogue Scale (VAS) Depressed Score | Day 7 | 65.576 Scores on a scale | Standard Error 6.264 |
| Placebo | Visual Analogue Scale (VAS) Depressed Score | 60 minutes | 60.562 Scores on a scale | Standard Error 6.197 |
| Placebo | Visual Analogue Scale (VAS) Depressed Score | Day 1 | 64.762 Scores on a scale | Standard Error 6.197 |
| Placebo | Visual Analogue Scale (VAS) Depressed Score | 80 minutes | 57.662 Scores on a scale | Standard Error 6.197 |
| Placebo | Visual Analogue Scale (VAS) Depressed Score | Day 3 | 63.312 Scores on a scale | Standard Error 6.197 |
| Placebo | Visual Analogue Scale (VAS) Depressed Score | 110 minutes | 59.062 Scores on a scale | Standard Error 6.197 |
| Placebo | Visual Analogue Scale (VAS) Depressed Score | Day 2 | 63.262 Scores on a scale | Standard Error 6.197 |
| Placebo | Visual Analogue Scale (VAS) Depressed Score | 230 minutes | 61.212 Scores on a scale | Standard Error 6.197 |
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AZD6765 (150 mg) | Young Mania Rating Scale (YMRS) Score. | 60 minutes | 4.294 Units on a scale | Standard Error 0.412 |
| AZD6765 (150 mg) | Young Mania Rating Scale (YMRS) Score. | 80 minutes | 3.748 Units on a scale | Standard Error 0.412 |
| AZD6765 (150 mg) | Young Mania Rating Scale (YMRS) Score. | 110 minutes | 3.475 Units on a scale | Standard Error 0.412 |
| AZD6765 (150 mg) | Young Mania Rating Scale (YMRS) Score. | 230 minutes | 3.748 Units on a scale | Standard Error 0.412 |
| AZD6765 (150 mg) | Young Mania Rating Scale (YMRS) Score. | Day 1 | 3.748 Units on a scale | Standard Error 0.412 |
| AZD6765 (150 mg) | Young Mania Rating Scale (YMRS) Score. | Day 2 | 3.699 Units on a scale | Standard Error 0.419 |
| AZD6765 (150 mg) | Young Mania Rating Scale (YMRS) Score. | Day 3 | 4.270 Units on a scale | Standard Error 0.419 |
| AZD6765 (150 mg) | Young Mania Rating Scale (YMRS) Score. | Day 7 | 4.366 Units on a scale | Standard Error 0.419 |
| Placebo | Young Mania Rating Scale (YMRS) Score. | Day 7 | 4.339 Units on a scale | Standard Error 0.435 |
| Placebo | Young Mania Rating Scale (YMRS) Score. | 60 minutes | 3.626 Units on a scale | Standard Error 0.427 |
| Placebo | Young Mania Rating Scale (YMRS) Score. | Day 1 | 3.326 Units on a scale | Standard Error 0.427 |
| Placebo | Young Mania Rating Scale (YMRS) Score. | 80 minutes | 3.526 Units on a scale | Standard Error 0.427 |
| Placebo | Young Mania Rating Scale (YMRS) Score. | Day 3 | 3.476 Units on a scale | Standard Error 0.427 |
| Placebo | Young Mania Rating Scale (YMRS) Score. | 110 minutes | 3.526 Units on a scale | Standard Error 0.427 |
| Placebo | Young Mania Rating Scale (YMRS) Score. | Day 2 | 3.676 Units on a scale | Standard Error 0.427 |
| Placebo | Young Mania Rating Scale (YMRS) Score. | 230 minutes | 3.526 Units on a scale | Standard Error 0.427 |