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OpenTrials
Completed

NCT Number: NCT00986479

This is a Study to Determine the Antidepressant Effects of AZD6765

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

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Key information

Conditions

Treatment Resistant Major Depressive Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Bethesda, Maryland, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD6765

Drug

Single IV infusion of 150 mg AZD6765.

Placebo to AZD6765

Drug

Single IV infusion of Placebo to AZD6765

Primary outcomes

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

    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.

    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 outcomes

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

    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.

    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.

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

    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.

    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.

  3. Scale for Suicide Ideation (SSI) Total Score.

    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.

    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.

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

    Time frame: 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.

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

    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

    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.

  6. Visual Analogue Scale (VAS) Depressed Score

    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

    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.

  7. Clinician-Administered Dissociative States Scale (CADSS) Score.

    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

    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.

  8. Brief Psychiatric Rating Scale (BPRS) Score.

    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.

    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.

  9. Beck Depression Inventory (BDI) Score.

    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.

    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.

  10. Young Mania Rating Scale (YMRS) Score.

    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.

    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.

  11. Visual Analogue Scale (VAS) Anxious Score.

    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.

    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.

  12. Brief Psychiatric Rating Scale (BPRS) Positive Score.

    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.

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2009
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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