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OpenTrials
Completed

NCT Number: NCT01724112

Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD)

This study will determine the efficacy, safety, and tolerability of a 40 milligrams (mg) once-daily (QD) dose of LY2940094 for 8 weeks in participants with MDD.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., North Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have a diagnosis of MDD without psychotic features as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
  • Have clinically significant depressive symptoms defined by a GRID Hamilton Depression Rating Scale 17 (HAMD17) Total Score ≥20 at screening
  • Body mass index (BMI) between 18 and 35 kilogram per square meter (kg/m²)

Exclusion criteria

  • Have a current or previous diagnosis of bipolar I or II disorder, MDD with psychotic features, schizoaffective disorder, schizophrenia, or other psychotic disorder
  • Currently meeting the criteria of treatment-resistant depression defined as ≥2 documented, failed treatment trials of adequate dose and duration with a registered antidepressant during the current depressive episode
  • Had electroconvulsive treatment, transcranial magnetic stimulation, vagal nerve stimulation for symptoms of depression in the 6 months prior to screening
  • Have any clinically significant medical or uncontrolled condition or circumstance prior to randomization that could affect participant safety

Treatment and study plan

LY2940094

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

  1. Change from Baseline to Week 8 on the GRID Hamilton Depression Rating Scale 17 Item Version (GRID-HAMD17) Total Score

    Time frame: Baseline, Week 8

Secondary outcomes

  1. Proportion of Participants Responding to Treatment

    Time frame: Baseline through Week 8

  2. Proportion of Participants who Achieved Remission

    Time frame: Week 8

  3. Change from Baseline to Week 8 in Maier-Philipp Subscale (MPS) Score

    Time frame: Baseline,Week 8

  4. Clinical Global Impression - Improvement (CGI-I) Score at Week 8

    Time frame: Week 8

  5. Change from Baseline to Week 8 in the Clinical Global Impression - Severity (CGI-S) Score

    Time frame: Baseline, Week 8

  6. Change from Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HAM-A) Total Score

    Time frame: Baseline, Week 4

  7. Change from Baseline to Week 8 in the Hospital Anxiety and Depression Scale (HADS) Score

    Time frame: Baseline, Week 8

  8. Population Pharmacokinetic (PK) Model: Estimate of LY2940094 Area Under the Curve (AUC)

    Time frame: Baseline through 8 Weeks of Treatment

Sponsors and collaborators

Lead sponsor

BlackThorn Therapeutics, Inc.

Industry

Registry information

Official study title

8-Week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of LY2940094 Administered Once Daily in Patients With Major Depressive Disorder (MDD)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 9, 2012
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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