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

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ClinicalTrials.gov Identifier: NCT01098240
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : April 2, 2010
Results First Posted : June 26, 2013
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 1, 2010
First Posted Date  ICMJE April 2, 2010
Results First Submitted Date  ICMJE September 18, 2012
Results First Posted Date  ICMJE June 26, 2013
Last Update Posted Date July 29, 2019
Study Start Date  ICMJE June 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2010)
  • Change from double blind baseline in MADRS total score at Week 14 (after 6 weeks of double blind therapy). [ Time Frame: 6 weeks ]
  • Vital signs, ECG, adverse events, physical examination findings, safety laboratory assessments, STS score. [ Time Frame: 6 weeks ]
Change History Complete list of historical versions of study NCT01098240 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
  • 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).
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2010)
  • Change from double blind baseline at Weeks 9-14 in HAM D25 total score, Bech Melancholia subscale score, CGI S score, SDS score, and at Weeks 11 and 14 in SIS score. [ Time Frame: 2 and 6 weeks ]
  • Change from double-blind baseline at Weeks 9-13 in MADRS total score. [ Time Frame: Weekly ]
  • Total CGI I score at Weeks 9-14. [ Time Frame: Weekly ]
  • Response rates, defined as >50% reduction from double-blind baseline in MADRS total score, at Weeks 9-14. [ Time Frame: Weekly ]
  • Remission rates, defined as response plus an absolute MADRS total score of less than or equal to 10 plus a CGI I score <2 ("much" or "very much" improved), at Weeks 9-14. [ Time Frame: Weekly ]
Current Other Pre-specified Outcome Measures
 (submitted: May 17, 2013)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression
Official Title  ICMJE 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
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Active Treatment
    CP-601,927
    Intervention: Drug: CP-601,927
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Fava M, Ramey T, Pickering E, Kinrys G, Boyer S, Altstiel L. A randomized, double-blind, placebo-controlled phase 2 study of the augmentation of a nicotinic acetylcholine receptor partial agonist in depression: is there a relationship to leptin levels? J Clin Psychopharmacol. 2015 Feb;35(1):51-6. doi: 10.1097/JCP.0000000000000245.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 17, 2013)
297
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2010)
198
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01098240
Other Study ID Numbers  ICMJE A3331017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP