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

April 7, 2021 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
297

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72223
        • Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
    • California
      • Beverly Hills, California, United States, 90210
        • Southwestern Research Incorporated
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, Inc.
      • National City, California, United States, 91950
        • Synergy Clinical Research Center
      • San Diego, California, United States, 92123
        • Artemis Institute for Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80239
        • Radiant Research, Inc.
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Comprehensive Psychiatric Care
      • Norwich, Connecticut, United States, 06360
        • William B. Backus Hospital Satellite Blood Draw
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Clinical Neuroscience Solutions, Inc.
      • Maitland, Florida, United States, 32751
        • Florida Clinical Research Center, LLC
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions, Inc.
      • Saint Petersburg, Florida, United States, 33716
        • Comprehensive NeuroScience, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30328
        • Atlanta Institute of Medicine and Research
    • Illinois
      • Naperville, Illinois, United States, 60563
        • AMR-Baber Research Inc.
      • Skokie, Illinois, United States, 60076
        • Psychiatric Medicine Associates, LLC.
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Goldpoint Clinical Research, LLC
      • Terre Haute, Indiana, United States, 47802
        • Clinco
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Louisiana
      • Lake Charles, Louisiana, United States, 70629
        • Lake Charles Clinical Trials
      • New Orleans, Louisiana, United States, 70114
        • Louisiana Research Associates, Inc.
      • Shreveport, Louisiana, United States, 71115
        • Louisiana Clinical Research, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02171
        • Massachusetts General Hospital
      • Fall River, Massachusetts, United States, 02721
        • AccelRx Research
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Rochester Center for Behavioral Medicine
      • Rochester Hills, Michigan, United States, 48307
        • Detroit Bio-Medical Laboratories, Inc.
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • St. Charles Psychiatric Associates - Midwest Research Group
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Center For Emotional Fitness
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Brooklyn, New York, United States, 11235
        • Social Psychiatry Research Institute
      • Buffalo, New York, United States, 14215
        • Erie County Medical Center / State University of New York at Buffalo affiliate
      • Fresh Meadows, New York, United States, 11366
        • Comprehensive NeuroScience, Inc.
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center
      • Toledo, Ohio, United States, 43623
        • Neurology and Neuroscience Center of Ohio
      • Toledo, Ohio, United States, 43609
        • Kettlie Joseph Daniels, MD, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Cutting Edge Research Group
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network (Oregon), Inc.
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Health Network
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • City Line Family Medicine
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania / Department of Psychiatry
      • Philadelphia, Pennsylvania, United States, 19136
        • Frankford Avenue Family Practice, PC
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Lincoln Research
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Carolina Clinical Research Service LLC
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, L.P.
      • Dallas, Texas, United States, 75235
        • University of Texas (UT) Southwestern Medical Center at Dallas
      • Dallas, Texas, United States, 75390-9119
        • University of Texas (UT) Southwestern Medical Center at Dallas
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Radiant Research, Inc
      • Salt Lake City, Utah, United States, 84132
        • University of Utah School of Medicine Department of Psychiatry Mood Disorders Clinic
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System / Department of Psychiatry and Neurobehavioral Sciences
      • Richmond, Virginia, United States, 23219
        • Mcguire Hall Annex
      • Richmond, Virginia, United States, 23219
        • Nelson Clinic
      • Richmond, Virginia, United States, 23298-0155
        • Virginia Commonwealth University (VCU) Medical Center
    • Wisconsin
      • Brown Deer, Wisconsin, United States, 53223
        • Northbrooke Research Center
      • Middleton, Wisconsin, United States, 53562
        • Dean Foundation for Health, Research and Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo
Matching placebo tablets, taken orally, twice per day, for 6 weeks.
Experimental: Active Treatment
CP-601,927
Drug: CP-601,927
CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14
Time Frame: Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Weeks 9 Through 13
Time Frame: Week 8 (double-blind baseline) and 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
Change From Double-blind Baseline in Hamilton Depression Scale 25-item (HAM-D25) - Total Score at Weeks 9 Through 14
Time Frame: Weeks 8 (double-blind baseline) 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
Change From Double-blind Baseline in Bech Melancholia Subscale Score at Weeks 9 Through 14
Time Frame: Weeks 8 (double-blind baseline) 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
Change From Double-blind Baseline in Clinical Global Impression - Severity (CGI-S) at Weeks 9, 10, 12, and 14
Time Frame: Week 8 (double-blind baseline) and weeks 9, 10, 12, 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
Change From Double-blind Baseline in Sheehan Irritability Scale (SIS) Total Score at Weeks 11 and 14
Time Frame: Weeks 8 (double-blind baseline), 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
Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 11 and 14
Time Frame: Weeks 8 (double-blind baseline), 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
Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Subscale Score at Weeks 11 and 14
Time Frame: Weeks 8 (double-blind baseline), 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
Clinical Global Impression - Improvement (CGI-I) Total Score at Weeks 9, 10, 12 and 14
Time Frame: Weeks 8 (double-blind baseline) 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
Number of Participants With Remission at Weeks 9, 10, 12 and 14
Time Frame: 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
Number of Participants With Response at Weeks 9 Through 14
Time Frame: 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
Population Pharmacokinetics
Time Frame: Weeks 11,12 and 14
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
Plasma CP-601,927 Concentration
Time Frame: Week 11, 12 and 14
Blood samples were collected for plasma CP-601,927 concentration analysis which was summarized by mean and standard deviation.
Week 11, 12 and 14

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Sheehan Suicidality Tracking Scale (STS)
Time Frame: Week 8 (double-blind baseline) and weeks 9 through 14
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3331017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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