Phase IIA Study in Patients With Schizophrenia

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. Identifier: NCT00686998
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : June 23, 2011
Last Update Posted : March 29, 2013
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: AZD2624
Drug: Olanzapine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 2 centers in the US were initiated and enrolled patients. 159 patients enrolled, of which 106 randomized

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened up to 21 days, and admitted to the Clinical Research Unit (CRU) for a maximum of 2 days until eligibility was determined. Once eligibility was determined, patients currently on medication entered a 7 days washout period, patients not currently on medication had a 3 day washout, prior to randomization to study medication.

Reporting Groups
AZD2624 AZD2624 40 mg
Placebo Matching Placebo
Olanzapine Olanzapine 15 mg

Participant Flow:   Overall Study
    AZD2624   Placebo   Olanzapine
STARTED   43 [1]   41 [1]   22 [1] 
Randomized   43   41   22 
Received Treatment   43   41   22 
Eligible for Efficacy Analysis   42   39   21 
Completed Scheduled Treatment   30   33   18 
COMPLETED   30   33   18 
NOT COMPLETED   13   8   4 
Adverse Event                3                2                1 
Withdrawal by Subject                2                1                2 
Lack of Efficacy                7                5                0 
Not specified                0                0                1 
Safety Reasons                1                0                0 
[1] Randomized & received study medication

  Baseline Characteristics

Population Description
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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Reporting Groups
AZD2624 AZD2624 40 mg
Placebo Matching Placebo
Olanzapine Olanzapine 15 mg
Total Total of all reporting groups

Baseline Measures
   AZD2624   Placebo   Olanzapine   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   41   22   106 
[Units: Year]
Mean (Standard Deviation)
 40.1  (12)   40.2  (11.6)   35.3  (8.7)   39.2  (11.3) 
[Units: Participants]
Female   3   2   0   5 
Male   40   39   22   101 

  Outcome Measures

1.  Primary:   Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline   [ Time Frame: Baseline, Day 28 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: Astrazeneca

Responsible Party: AstraZeneca Identifier: NCT00686998     History of Changes
Other Study ID Numbers: D0970C00004
First Submitted: May 28, 2008
First Posted: May 30, 2008
Results First Submitted: April 28, 2010
Results First Posted: June 23, 2011
Last Update Posted: March 29, 2013