Clinical trial NCT00570063: Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo
Official title: A Phase 2, Multicenter, Double-blind, Randomized, Fixed Dose, Parallel Group, 3-week Inpatient Treatment Study To Evaluate The Safety, Efficacy And Pharmacokinetics Of Pf-02545920 Compared With Placebo In The Treatment Of Acute Exacerbation Of Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
acute exacerbation
and PF-02545920
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of an investigational compound PF-02545920 for the treatment of schizophrenia. PF-02545920 will be more effective than placebo in reducing symptoms associated with schizophrenia.


Eligibility criteria: Inclusion Criteria:

1. Have a current diagnosis of schizophrenia.
2. Increase in symptoms over the past 2-4 weeks.
3. Willing to remain inpatients for the duration of the trial.

Exclusion Criteria:

1. Evidence or history of clinically significant medical problems.
2. Females of childbearing potential.
3. A primary psychiatric diagnosis other than schizophrenia.
4. A diagnosis of substance abuse or dependence in the last 6 months.

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score
timeFrame: Baseline (Day 1), Day 21
Secondary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21
timeFrame: Baseline (Day 4), Day 21
measure: Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21
timeFrame: Baseline (Day 1), Day 21
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline (Day 1) up to Day 31
measure: Number of Participants With Vital Signs of Potential Clinical Concern
timeFrame: Baseline (Day 1) up to Day 31
measure: Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities
timeFrame: Baseline (Day 1) up to Day 31
measure: Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern
timeFrame: Baseline (Day 1) up to Day 31
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline (Day 1) up to Day 31
measure: Number of Participants With Abnormal Prolactin Level
timeFrame: Baseline (Day 1) up to Day 21
measure: Number of Participants With Abnormal High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Level
timeFrame: Baseline up to Day 21
measure: Number of Participants With Abnormal Glycosylated Hemoglobin (HbA1c) Level
timeFrame: Baseline (Day 1) up to Day 21
measure: Number of Participants With Abnormal Fasting Insulin Level
timeFrame: Baseline (Day 1) up to Day 21
measure: Change From Baseline in Body Weight at Day 21
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Abdominal Girth at Day 21
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21
timeFrame: Baseline (Day 1), Day 4, 7, 14, 21
measure: Oral Clearance (CL/F) of PF-02545920
timeFrame: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21
measure: Area Under the Concentration Time Curve (AUC) of PF-02545920
timeFrame: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21
measure: Steady State Average Concentration of PF-02545920 Over the Dosing Interval (Css,Avg)
timeFrame: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21
Locations:
city: Glendale
country: United States
facility: California Clinical Trials Medical Group, Inc.
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Lemon Grove
country: United States
facility: Telecare-Cresta Loma
state: California
city: Paramount
country: United States
facility: California Clinical Trials Medical Group
state: California
city: Paramount
country: United States
facility: LaPaz Geropsychiatric Center
state: California
city: San Diego
country: United States
facility: California Clinical Trials Medical Group
state: California
city: New Haven
country: United States
facility: Connecticut Mental Health Center-Yale University, Clinical Neuroscience Research Unit
state: Connecticut
city: Willingboro
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Oklahoma City
country: United States
facility: St. Anthony Hospital
state: Oklahoma
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: