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NCT03697109 · OUTCOME

Change in Beck Depression Inventory-II (BDI-II) Score During the OL Phase

A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome · Source last updated 2025-07-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline and Week 22 (end of OL Phase)

What was measured

The BDI-II is a 21-question self-report inventory that measures depression. Each answer is scored with values of 0 to 3. The total score ranges from 0 to 63. Scores of 0 to 13 indicate minimal depression, 14 to 19; mild depression; 20 to 28; moderate depression; 29 to 63; severe depression.

Analysis population: The analysis population was patients in the mITT-OL Population.

Groups in this outcome

Relacorilant (OL Phase)

Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Relacorilant (OL Phase)151

Reported measurements

Baseline BDI-II Score

Analysis denominator · Participants

GroupSource count
Relacorilant (OL Phase)151
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Relacorilant (OL Phase)16.010.24Not reportedNot reportedNot reported
Change from Baseline in BDI-II Score at Week 22

Analysis denominator · Participants

GroupSource count
Relacorilant (OL Phase)99
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Relacorilant (OL Phase)-2.88.91Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.24
        value
        16.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        151
      units
      Participants
    title
    Baseline BDI-II Score
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.91
        value
        -2.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        99
      units
      Participants
    title
    Change from Baseline in BDI-II Score at Week 22
denoms
  1. counts
    1. group Id
      OG000
      value
      151
    units
    Participants
description
The BDI-II is a 21-question self-report inventory that measures depression. Each answer is scored with values of 0 to 3. The total score ranges from 0 to 63. Scores of 0 to 13 indicate minimal depression, 14 to 19; mild depression; 20 to 28; moderate depression; 29 to 63; severe depression.
dispersion Type
Standard Deviation
groups
  1. description
    Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.
    id
    OG000
    title
    Relacorilant (OL Phase)
param Type
MEAN
population Description
The analysis population was patients in the mITT-OL Population.
reporting Status
POSTED
time Frame
Baseline and Week 22 (end of OL Phase)
title
Change in Beck Depression Inventory-II (BDI-II) Score During the OL Phase
type
OTHER_PRE_SPECIFIED
unit Of Measure
score on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice