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This is a Study to Determine the Antidepressant Effects of AZD6765

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00986479
Recruitment Status : Completed
First Posted : September 30, 2009
Results First Posted : October 21, 2014
Last Update Posted : October 21, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Treatment Resistant Major Depressive Disorder
Interventions Drug: AZD6765
Drug: Placebo to AZD6765
Enrollment 22
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.
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description 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.
Period Title: Period 1
Started 12 10
Completed 10 10
Not Completed 2 0
Reason Not Completed
Improved mood             1             0
Administrative reasons             1             0
Period Title: Period 2
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title AZD6765 (150 mg)/ Placebo Placebo/AZD6765 (150 mg) Total
Hide Arm/Group Description 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. Total of all reporting groups
Overall Number of Baseline Participants 12 10 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 10 participants 22 participants
50.7  (10.9) 52.4  (10.5) 51.5  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
Female
7
  58.3%
3
  30.0%
10
  45.5%
Male
5
  41.7%
7
  70.0%
12
  54.5%
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population including all randomized patients who were given study treatment.
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22 20
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
60 minutes 26.881  (1.262) 28.618  (1.314)
80 minutes 25.381  (1.262) 29.718  (1.314)
110 minutes 25.835  (1.262) 29.818  (1.314)
230 minutes 26.517  (1.262) 29.418  (1.314)
Day 1 27.654  (1.262) 29.118  (1.314)
Day 2 29.161  (1.288) 31.368  (1.314)
Day 3 30.732  (1.288) 30.368  (1.314)
Day 7 31.447  (1.288) 31.222  (1.342)
2.Secondary Outcome
Title The Number of Participants With Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than 10 (MADRS Remission).
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population including all randomized patients who were given study treatment.
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22 20
Measure Type: Number
Unit of Measure: Participants
60 minutes 2 1
80 minutes 4 0
110 minutes 4 0
230 minutes 2 0
Day 1 2 0
Day 2 1 0
Day 3 1 0
Day 7 1 0
3.Secondary Outcome
Title The Number of Participants With at Least 50% Reduction in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (MADRS Response).
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population including all randomized patients who were given study treatment.
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22 20
Measure Type: Number
Unit of Measure: Participants
60 minutes 5 3
80 minutes 6 1
110 minutes 4 0
230 minutes 4 1
Day 1 3 0
Day 2 1 0
Day 3 1 0
Day 7 1 0
4.Secondary Outcome
Title Scale for Suicide Ideation (SSI) Total Score.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population including all randomized patients who were given study treatment.
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22 20
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
60 minutes 0.955  (0.326) 0.939  (0.330)
80 minutes 1.137  (0.326) 1.039  (0.330)
110 minutes 1.137  (0.326) 0.989  (0.330)
230 minutes 0.864  (0.326) 0.939  (0.330)
Day 1 1.364  (0.326) 1.539  (0.330)
Day 2 1.236  (0.328) 1.189  (0.330)
Day 3 1.379  (0.328) 1.226  (0.332)
Day 7 1.379  (0.328) 1.507  (0.332)
5.Secondary Outcome
Title Hamilton Anxiety Rating Scale (HAM-A) Total Score.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22 20
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
230 minutes 16.211  (1.181) 17.160  (1.207)
Day 1 16.666  (1.181) 17.675  (1.198)
Day 2 16.817  (1.190) 18.125  (1.198)
Day 3 17.055  (1.190) 18.525  (1.198)
Day 7 18.817  (1.190) 19.631  (1.207)
6.Secondary Outcome
Title Hamilton Depression Rating Scale-17 Item (HDRS) Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population including all randomized patients who were given study treatment.
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22 20
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
60 minutes 15.930  (0.977) 17.389  (1.008)
80 minutes 14.975  (0.977) 17.739  (1.008)
110 minutes 15.475  (0.977) 18.039  (1.008)
230 minutes 16.112  (0.977) 17.339  (1.008)
Day 1 16.748  (0.977) 17.639  (1.008)
Day 2 16.732  (0.977) 19.289  (1.008)
Day 3 17.732  (0.977) 19.039  (1.008)
Day 7 18.160  (0.991) 19.438  (1.024)
7.Secondary Outcome
Title Visual Analogue Scale (VAS) Depressed Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population including all randomized patients who were given study treatment.
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22 20
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
60 minutes 55.614  (6.137) 60.562  (6.197)
80 minutes 58.614  (6.137) 57.662  (6.197)
110 minutes 60.750  (6.137) 59.062  (6.197)
230 minutes 55.614  (6.137) 61.212  (6.197)
Day 1 62.160  (6.137) 64.762  (6.197)
Day 2 65.753  (6.166) 63.262  (6.197)
Day 3 66.896  (6.166) 63.312  (6.197)
Day 7 68.467  (6.166) 65.576  (6.264)
8.Secondary Outcome
Title Clinician-Administered Dissociative States Scale (CADSS) Score.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population including all randomized patients who were given study treatment.
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22 20
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
60 minutes 4.104  (0.900) 1.997  (0.921)
80 minutes 3.324  (0.909) 2.297  (0.921)
110 minutes 2.831  (0.900) 2.047  (0.921)
230 minutes 1.240  (0.900) 1.497  (0.921)
Day 1 1.013  (0.900) 1.147  (0.921)
Day 2 1.360  (0.910) 1.397  (0.921)
Day 3 1.456  (0.910) 1.447  (0.921)
Day 7 1.313  (0.910) 1.212  (0.932)
9.Secondary Outcome
Title Brief Psychiatric Rating Scale (BPRS) Score.
Hide Description

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.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population including all randomized patients who were given study treatment.
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22 20
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
60 minutes 32.191  (1.271) 32.896  (1.314)
80 minutes 30.237  (1.271) 33.496  (1.314)
110 minutes 30.555  (1.271) 33.696  (1.314)
230 minutes 30.737  (1.271) 31.772  (1.314)
Day 1 33.418  (1.271) 33.596  (1.314)
Day 2 32.882  (1.291) 34.496  (1.314)
Day 3 34.168  (1.291) 33.046  (1.314)
Day 7 35.739  (1.291) 34.428  (1.335)
10.Secondary Outcome
Title Beck Depression Inventory (BDI) Score.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population including all randomized patients who were given study treatment.
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22 20
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
60 minutes 21.081  (2.524) 22.886  (2.538)
80 minutes 22.217  (2.524) 23.122  (2.546)
110 minutes 21.535  (2.524) 23.586  (2.538)
230 minutes 21.126  (2.524) 23.686  (2.538)
Day 1 22.444  (2.524) 22.936  (2.538)
Day 2 22.923  (2.531) 24.586  (2.538)
Day 3 23.494  (2.531) 23.786  (2.538)
Day 7 24.447  (2.531) 24.070  (2.546)
11.Secondary Outcome
Title Young Mania Rating Scale (YMRS) Score.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population including all randomized patients who were given study treatment.
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22 20
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
60 minutes 4.294  (0.412) 3.626  (0.427)
80 minutes 3.748  (0.412) 3.526  (0.427)
110 minutes 3.475  (0.412) 3.526  (0.427)
230 minutes 3.748  (0.412) 3.526  (0.427)
Day 1 3.748  (0.412) 3.326  (0.427)
Day 2 3.699  (0.419) 3.676  (0.427)
Day 3 4.270  (0.419) 3.476  (0.427)
Day 7 4.366  (0.419) 4.339  (0.435)
12.Secondary Outcome
Title Visual Analogue Scale (VAS) Anxious Score.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population including all randomized patients who were given study treatment.
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22 20
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
60 minutes 43.898  (7.415) 41.929  (7.479)
80 minutes 44.216  (7.415) 44.079  (7.479)
110 minutes 42.853  (7.415) 44.729  (7.479)
230 minutes 44.580  (7.415) 46.029  (7.479)
Day 1 44.989  (7.415) 47.229  (7.479)
Day 2 44.718  (7.447) 50.479  (7.479)
Day 3 42.623  (7.447) 48.279  (7.479)
Day 7 50.147  (7.447) 56.595  (7.551)
13.Secondary Outcome
Title Brief Psychiatric Rating Scale (BPRS) Positive Score.
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22 20
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
60 minutes 9.433  (0.264) 8.946  (0.274)
80 minutes 8.751  (0.264) 8.996  (0.274)
110 minutes 8.660  (0.264) 8.996  (0.274)
230 minutes 8.751  (0.264) 8.666  (0.279)
Day 1 9.114  (0.264) 9.296  (0.274)
Day 2 9.118  (0.269) 9.296  (0.274)
Day 3 9.118  (0.269) 9.446  (0.274)
Day 7 9.356  (0.269) 9.338  (0.279)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD6765 (150 mg) Placebo
Hide Arm/Group Description 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.
All-Cause Mortality
AZD6765 (150 mg) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZD6765 (150 mg) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD6765 (150 mg) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   21/22 (95.45%)   20/20 (100.00%) 
Cardiac disorders     
Bradycardia   1/22 (4.55%)  1/20 (5.00%) 
Tachycardia   2/22 (9.09%)  2/20 (10.00%) 
Ear and labyrinth disorders     
Hypoacusis   1/22 (4.55%)  0/20 (0.00%) 
Tinnitus   1/22 (4.55%)  2/20 (10.00%) 
Hearing impaired   3/22 (13.64%)  2/20 (10.00%) 
Eye disorders     
Vision blurred   2/22 (9.09%)  1/20 (5.00%) 
Eye irritation   1/22 (4.55%)  1/20 (5.00%) 
Visual impairment   3/22 (13.64%)  1/20 (5.00%) 
Gastrointestinal disorders     
Constipation   3/22 (13.64%)  2/20 (10.00%) 
Flatulence   2/22 (9.09%)  3/20 (15.00%) 
Thirst   1/22 (4.55%)  0/20 (0.00%) 
Nausea   5/22 (22.73%)  3/20 (15.00%) 
Abdominal discomfort   6/22 (27.27%)  5/20 (25.00%) 
Faeces discoloured   1/22 (4.55%)  1/20 (5.00%) 
Vomiting   2/22 (9.09%)  0/20 (0.00%) 
Dry mouth   5/22 (22.73%)  3/20 (15.00%) 
Gingival disorder   1/22 (4.55%)  0/20 (0.00%) 
Salivary hypersecretion   1/22 (4.55%)  0/20 (0.00%) 
Mouth ulceration   1/22 (4.55%)  0/20 (0.00%) 
Glossodynia   1/22 (4.55%)  1/20 (5.00%) 
Malignant dysphagia   1/22 (4.55%)  1/20 (5.00%) 
General disorders     
Oedema   1/22 (4.55%)  1/20 (5.00%) 
Fatigue   6/22 (27.27%)  5/20 (25.00%) 
Pyrexia   2/22 (9.09%)  1/20 (5.00%) 
Energy increased   5/22 (22.73%)  1/20 (5.00%) 
Infections and infestations     
Influenza   2/22 (9.09%)  1/20 (5.00%) 
Investigations     
Weight increased   1/22 (4.55%)  0/20 (0.00%) 
Weight decreased   2/22 (9.09%)  1/20 (5.00%) 
Body temperature decreased   5/22 (22.73%)  4/20 (20.00%) 
Body temperature increased   5/22 (22.73%)  3/20 (15.00%) 
Metabolism and nutrition disorders     
Decreased apetite   9/22 (40.91%)  5/20 (25.00%) 
Increased apetite   1/22 (4.55%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders     
Muscle rigidity   2/22 (9.09%)  0/20 (0.00%) 
Myalgia   3/22 (13.64%)  2/20 (10.00%) 
Nervous system disorders     
Dysgeusia   1/22 (4.55%)  1/20 (5.00%) 
Libido increased   1/22 (4.55%)  0/20 (0.00%) 
Felt faint   10/22 (45.45%)  3/20 (15.00%) 
Headache   2/22 (9.09%)  4/20 (20.00%) 
Tremor   3/22 (13.64%)  4/20 (20.00%) 
Irritability   10/22 (45.45%)  8/20 (40.00%) 
Memory impairment   5/22 (22.73%)  5/20 (25.00%) 
Hypokinesia   7/22 (31.82%)  6/20 (30.00%) 
Dysarthria   3/22 (13.64%)  1/20 (5.00%) 
Suicidal behaviour   1/22 (4.55%)  0/20 (0.00%) 
Suicidal ideation   2/22 (9.09%)  3/20 (15.00%) 
Euphoric mood   3/22 (13.64%)  0/20 (0.00%) 
Abnormal behaviour   8/22 (36.36%)  3/20 (15.00%) 
Hypoaesthesia   6/22 (27.27%)  2/20 (10.00%) 
Paraesthesia   6/22 (27.27%)  2/20 (10.00%) 
Abnormal dreams   3/22 (13.64%)  5/20 (25.00%) 
Dizziness   10/22 (45.45%)  4/20 (20.00%) 
Psychiatric disorders     
Tic   1/22 (4.55%)  1/20 (5.00%) 
Anxiety   2/22 (9.09%)  3/20 (15.00%) 
Disturbance in attention   10/22 (45.45%)  6/20 (30.00%) 
Confusional state   6/22 (27.27%)  1/20 (5.00%) 
Depression   4/22 (18.18%)  1/20 (5.00%) 
Initial insomnia   7/22 (31.82%)  8/20 (40.00%) 
Somnolence   15/22 (68.18%)  12/20 (60.00%) 
Terminal insomnia   6/22 (27.27%)  7/20 (35.00%) 
Hallucination   0/22 (0.00%)  1/20 (5.00%) 
Sleep disorder   10/22 (45.45%)  11/20 (55.00%) 
Psychomotor activity   5/22 (22.73%)  4/20 (20.00%) 
Dissociation   3/22 (13.64%)  2/20 (10.00%) 
Social avoindant behaviour   4/22 (18.18%)  3/20 (15.00%) 
Feeling abnormal   5/22 (22.73%)  3/20 (15.00%) 
Fear of falling   2/22 (9.09%)  0/20 (0.00%) 
False Sensation   9/22 (40.91%)  6/20 (30.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea   2/22 (9.09%)  0/20 (0.00%) 
Nasal congestion   4/22 (18.18%)  2/20 (10.00%) 
Oropharyngeal pain   1/22 (4.55%)  1/20 (5.00%) 
Skin and subcutaneous tissue disorders     
Skin irritation   3/22 (13.64%)  3/20 (15.00%) 
Hyperhidrosis   2/22 (9.09%)  1/20 (5.00%) 
Rash   3/22 (13.64%)  0/20 (0.00%) 
Surgical and medical procedures     
Dental care   1/22 (4.55%)  1/20 (5.00%) 
Surgery   1/22 (4.55%)  0/20 (0.00%) 
Vascular disorders     
Hypertension   8/22 (36.36%)  5/20 (25.00%) 
Hypotension   3/22 (13.64%)  1/20 (5.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Clinical Trial Transparency
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00986479     History of Changes
Obsolete Identifiers: NCT00995111
Other Study ID Numbers: D6702C00015
First Submitted: September 24, 2009
First Posted: September 30, 2009
Results First Submitted: October 15, 2014
Results First Posted: October 21, 2014
Last Update Posted: October 21, 2014