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

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Pfizer

Status and phase

Terminated
Phase 2

Conditions

Major Depressive Disorder

Treatments

Drug: CP-601,927
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01098240
A3331017

Details and patient eligibility

About

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.

Full 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.

Enrollment

297 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

297 participants in 2 patient groups, including a placebo group

Active Treatment
Experimental group
Description:
CP-601,927
Treatment:
Drug: CP-601,927
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Other: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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