Study to Asses Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of AZD0328 in Patients With Schizophrenia

NCT00669903 | Terminated Phase 2 Results

• 1 other identifier: D0190C00007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This study is to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of multiple ascending doses of AZD0328 in patients with schizophrenia

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14

  The GMLT and OCLT standardized change composite score will be calculated as the mean of the GMLT and OCLT standardized change from baseline scores. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate. Scale range from negative infinity (worst value) to positive infinity (best value).

  Baseline and Day 14

Secondary Outcomes (5)

• CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14

  Baseline and Day 14

• CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14

  Baseline and Day 14

• CogState Detection Task (DT) Standardized Change Score at Day 14

  Baseline and Day 14

• CogState Identification Task (IT) Standardized Change Score at Day 14

  Baseline and Day 14

• CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14

  Baseline and Day 14

Study Arms (4)

1

EXPERIMENTAL

AZD0328 low dose

Drug: AZD0328

2

EXPERIMENTAL

AZD0328 Optimal dose

Drug: AZD0328

3

EXPERIMENTAL

AZD0328 High dose

Drug: AZD0328

4

PLACEBO COMPARATOR

Placebo Comparator

Drug: Placebo

Interventions

AZD0328 DRUG

1; 2; 3

Placebo DRUG

4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of schizophrenia according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)
• Low level of Extra-pyramidal symptoms
• No clinically significant findings on physical examination

You may not qualify if:

• Diagnosis of schizoaffective or schizophreniform disorders
• Any significant psychiatric or neurological disease other than schizophrenia

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Center

Garden Grove, California, United States

Location

Research Center

Glendale, California, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

spiro(1-azabicyclo(2.2.2)octane-3,2'(3H)-furo(2,3-b)pyridine)

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: August 6, 2010
• Results First Posted: August 6, 2010

Record last verified: 2010-07

Locations

US (2)