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

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.

Timeline

Start

2010-06-14

Primary completion

2011-09-12

Completion

2011-09-12

Outcome

Missed primary endpoint

Stopped: “See termination reason in detailed description.”

paper There was no significant difference in change from baseline to week 14 in the MADRS score for CP-610,927 versus placebo PMID 25422883 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CP-601,927	Small molecule	1 mg	Oral
Subject	CP-601,927	Small molecule	2 mg	Oral

Indications