A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression

Major Depressive Disorder Clinical Trial

Official title:

A RANDOMIZED PHASE 2A, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CP-601,927 AUGMENTATION OF ANTIDEPRESSANT THERAPY IN MAJOR DEPRESSION

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01098240
• Other study ID #: A3331017
• Status: Terminated
• Phase: Phase 2
• Start date: June 14, 2010
• Est. completion date: September 12, 2011

Study information

• Verified date: April 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to: 1) Evaluate the efficacy of CP 601,927 compared to placebo in the augmentation of antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD) using the Montgomery Asberg Depression Rating Scale (MADRS). 2) Evaluate the safety and tolerability of CP 601,927 in patients with MDD on ADT.

Description:

The study was stopped at interim analysis in August 2011, as stopping criteria for futility were met. There was no statistically significant change on the primary efficacy scale in favor of the drug. There was a very small chance that any additional data could change the study overall outcome. There were no concerns regarding subject safety.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 297
• Est. completion date: September 12, 2011
• Est. primary completion date: September 12, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Medically healthy males or females aged 18-65 (inclusive).

• Patients must have a primary current diagnosis of MDD without psychotic features.

• Patients must be receiving ongoing antidepressant therapy at the time of screening. Duration of the current episode of MDD must be at least 8 weeks prior to enrollment without adequate response to treatment.

Exclusion Criteria:

• Patients with other psychiatric disorders.

• Patients who use tobacco products.

• Alcohol or substance abuse or dependence.

• Treatment with a monoamine oxidase inhibitor within 10 weeks of enrollment.

• Pregnancy or breastfeeding.

• Clinically significant abnormalities on laboratory tests, electrocardiogram, or physical or neurologic examination.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• CP-601,927
CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks.

Other:
• Placebo
Matching placebo tablets, taken orally, twice per day, for 6 weeks.

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Atlanta Institute of Medicine and Research	Atlanta	Georgia
United States	FutureSearch Trials	Austin	Texas
United States	City Line Family Medicine	Bala-Cynwyd	Pennsylvania
United States	Southwestern Research Incorporated	Beverly Hills	California
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Social Psychiatry Research Institute	Brooklyn	New York
United States	Northbrooke Research Center	Brown Deer	Wisconsin
United States	Erie County Medical Center / State University of New York at Buffalo affiliate	Buffalo	New York
United States	University of Virginia Health System / Department of Psychiatry and Neurobehavioral Sciences	Charlottesville	Virginia
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Carolina Clinical Research Service LLC	Columbia	South Carolina
United States	FutureSearch Trials of Dallas, L.P.	Dallas	Texas
United States	University of Texas (UT) Southwestern Medical Center at Dallas	Dallas	Texas
United States	University of Texas (UT) Southwestern Medical Center at Dallas	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Radiant Research, Inc.	Denver	Colorado
United States	InSite Clinical Research	DeSoto	Texas
United States	AccelRx Research	Fall River	Massachusetts
United States	Comprehensive NeuroScience, Inc.	Fresh Meadows	New York
United States	Collaborative Neuroscience Network, Inc.	Garden Grove	California
United States	Goldpoint Clinical Research, LLC	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Lincoln Research	Lincoln	Rhode Island
United States	Arkansas Psychiatric Clinic Clinical Research Trials, P.A.	Little Rock	Arkansas
United States	Florida Clinical Research Center, LLC	Maitland	Florida
United States	Suburban Research Associates	Media	Pennsylvania
United States	Dean Foundation for Health, Research and Education	Middleton	Wisconsin
United States	AMR-Baber Research Inc.	Naperville	Illinois
United States	Synergy Clinical Research Center	National City	California
United States	Louisiana Research Associates, Inc.	New Orleans	Louisiana
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	William B. Backus Hospital Satellite Blood Draw	Norwich	Connecticut
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	IPS Research	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Frankford Avenue Family Practice, PC	Philadelphia	Pennsylvania
United States	University of Pennsylvania / Department of Psychiatry	Philadelphia	Pennsylvania
United States	Summit Research Network (Oregon), Inc.	Portland	Oregon
United States	Mcguire Hall Annex	Richmond	Virginia
United States	Nelson Clinic	Richmond	Virginia
United States	Virginia Commonwealth University (VCU) Medical Center	Richmond	Virginia
United States	Detroit Bio-Medical Laboratories, Inc.	Rochester Hills	Michigan
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	St. Charles Psychiatric Associates - Midwest Research Group	Saint Charles	Missouri
United States	Comprehensive NeuroScience, Inc.	Saint Petersburg	Florida
United States	Radiant Research, Inc	Salt Lake City	Utah
United States	University of Utah School of Medicine Department of Psychiatry Mood Disorders Clinic	Salt Lake City	Utah
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Louisiana Clinical Research, LLC	Shreveport	Louisiana
United States	Psychiatric Medicine Associates, LLC.	Skokie	Illinois
United States	Clinco	Terre Haute	Indiana
United States	Kettlie Joseph Daniels, MD, Inc.	Toledo	Ohio
United States	Neurology and Neuroscience Center of Ohio	Toledo	Ohio
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Sheehan Suicidality Tracking Scale (STS)	The Sheehan Suicidality Tracking Scale (STS) measures treatment-emergent suicidal ideation as well as behaviors. It can be administered by a clinician or filled in by a participant. Prior to analysis, the STS was mapped to the Columbia Classification Algorithm of Suicide Assessment(C-CASA) categories, which has 9-item including completed suicide, suicide attempt, preparatory acts, suicidal ideation, self-injurious behavior, self-injurious no intent, unknown fatal,unknown non-fatal or other not deliberate. Participants who were mapped to C-CASA items were reported.	Week 8 (double-blind baseline) and weeks 9 through 14
Primary	Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14	MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).	Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase)
Secondary	Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Weeks 9 Through 13	MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).	Week 8 (double-blind baseline) and weeks 9 through 13
Secondary	Change From Double-blind Baseline in Hamilton Depression Scale 25-item (HAM-D25) - Total Score at Weeks 9 Through 14	The HAM-D25 is the 25-item version of a scale used to assess the range of depressive symptoms including depressed mood, work and activities, sleep, suicidal thinking, psychomotor agitation/retardation, appetite, sexual interest, anxiety, somatic symptoms, and cognitive symptoms. The items on the HAM-D were rated on a scale of 0-2 or 0-4, for a total numeric range of scores from 0 (depressive symptoms absent) to 72 (numerically highest level of depressive symptoms).	Weeks 8 (double-blind baseline) through 14
Secondary	Change From Double-blind Baseline in Bech Melancholia Subscale Score at Weeks 9 Through 14	The Bech Melancholia is sum of scores on 6 items (items 1, 2, 7, 8, 10 and 13) pertaining to melancholia within HAM-D. The items are rated on a scale of 0-4, higher scores reflecting greater severity. Total possible score is 0-24.	Weeks 8 (double-blind baseline) through 14
Secondary	Change From Double-blind Baseline in Clinical Global Impression - Severity (CGI-S) at Weeks 9, 10, 12, and 14	CGI-S was defined as 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected.	Week 8 (double-blind baseline) and weeks 9, 10, 12, 14
Secondary	Change From Double-blind Baseline in Sheehan Irritability Scale (SIS) Total Score at Weeks 11 and 14	The SIS is to rate suffering with regard to irritability symptoms. The degree to which irritability interferes with work, social and family function is also queried. The total SIS score is the sum of 7 items. Each item is rated on a scale of 0-10, for a total numeric range of scores from 0 (not at all) to 70 (extremely). The SIS also records the number of days impaired by irritability.	Weeks 8 (double-blind baseline), 11 and 14
Secondary	Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 11 and 14	SDS is defined as a self-administered tool that measures functional impairment including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale (0=not at all impaired, 10=extremely impaired), for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).	Weeks 8 (double-blind baseline), 11 and 14
Secondary	Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Subscale Score at Weeks 11 and 14	SDS subscale is defined as a self-administered tool that measures functional impairment in 3-item including work/school, social life, and family life/home responsibilities. Items are rated on a scale of 0-10 visual analog scale, for a total numeric range of scores from 0 (not at all impaired) to 30 (extremely impaired).	Weeks 8 (double-blind baseline), 11 and 14
Secondary	Clinical Global Impression - Improvement (CGI-I) Total Score at Weeks 9, 10, 12 and 14	CGI-I was defined as a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.	Weeks 8 (double-blind baseline) 9, 10, 12 and 14
Secondary	Number of Participants With Remission at Weeks 9, 10, 12 and 14	Remission was defined as response plus an absolute MADRS total score of less than or equal to 10 plus a CGI-I score less than 2 ('much' or 'very much' improved).	Weeks 9, 10, 12 and 14
Secondary	Number of Participants With Response at Weeks 9 Through 14	Response was defined as greater than 50 percent reduction from double-blind baseline in MADRS total score.	Weeks 9 through 14
Secondary	Population Pharmacokinetics	Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-601,927 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-601,927 concentrations	Weeks 11,12 and 14
Secondary	Plasma CP-601,927 Concentration	Blood samples were collected for plasma CP-601,927 concentration analysis which was summarized by mean and standard deviation.	Week 11, 12 and 14

External Links

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