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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

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.

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

This is a study to determine the antidepressant effects of AZD6765

D6702C00015 Clinical Study Report Synopsis

Research Site

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

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.

Age Continuous

Gender, Male/Female

60 minutes

80 minutes

110 minutes

230 minutes

Day 1

Day 2

Day 3

Day 7

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

Montgomery-Asberg Depression Rating Scale (MADRS) total score.

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.

The number of participants with Montgomery-Asberg Depression Rating Scale (MADRS) total score less than 10 (MADRS Remission).

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.

The number of participants with at least 50% reduction in Montgomery-Asberg Depression Rating Scale (MADRS) total score (MADRS Response).

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.

Scale for Suicide Ideation (SSI) 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.

Hamilton Anxiety Rating Scale (HAM-A) 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.

Hamilton Depression Rating Scale-17 item (HDRS) total 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.

Visual Analogue Scale (VAS) Depressed 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.

Clinician-Administered Dissociative States Scale (CADSS) 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.

Brief Psychiatric Rating Scale (BPRS) 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.

Beck Depression Inventory (BDI) 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.

Young Mania Rating Scale (YMRS) 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.

Visual Analogue Scale (VAS) Anxious score.

110  minutes

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.

Arms	Assigned Interventions
Experimental: 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.	Drug: AZD6765 Single IV infusion of 150 mg AZD6765.
Placebo Comparator: 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.	Drug: Placebo to AZD6765 Single IV infusion of Placebo to AZD6765

This is a study to determine the antidepressant effects of AZD6765

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Actual Enrollment

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Study design

Verification:

Sponsors

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Inclusion Criteria

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Documents available

D6702C00015 Clinical Study Report Synopsis

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator