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NCT03180294 · OUTCOME

Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score ("Depressive Mood")

Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer · Source last updated 2026-07-10

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Error
Time frame
Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)

What was measured

The PHQ-4 is a brief screening questionnaire for depression. Possible scores range from 0 to 12, with higher scores indicating more severe depression. Change score is calculated by subtracting baseline from later score, with a negative change score indicating decreased severity of depression. This measure is referred to as "depressive mood" in the protocol.

Analysis population: Eligible with baseline data

Groups in this outcome

Bupropion 150 mg

One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).

Bupropion 300 mg

One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)

Placebo

One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)

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

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg79
Bupropion 300 mg74
Placebo77

Reported measurements

Week 5

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg66
Bupropion 300 mg60
Placebo62
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Bupropion 150 mg-0.441.77Not reportedNot reportedNot reported
Bupropion 300 mg-0.171.91Not reportedNot reportedNot reported
Placebo-0.162.29Not reportedNot reportedNot reported
Week 9

Analysis denominator · Participants

GroupSource count
Bupropion 150 mg65
Bupropion 300 mg61
Placebo63
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Bupropion 150 mg-0.421.68Not reportedNot reportedNot reported
Bupropion 300 mg-0.431.86Not reportedNot reportedNot reported
Placebo-0.432.39Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    Week 5
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.78
    p Value Comment
    One-sided significance level 0.05
    statistical Method
    t-test, 1 sided
  2. group Description
    Week 5
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.51
    p Value Comment
    One-sided significance level 0.05
    statistical Method
    t-test, 1 sided
  3. group Description
    Week 9
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.49
    p Value Comment
    One-sided significance level 0.05
    statistical Method
    t-test, 1 sided
  4. group Description
    Week 9
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.50
    p Value Comment
    One-sided significance level 0.05
    statistical Method
    t-test, 1 sided
Complete source fields
analyses
  1. group Description
    Week 5
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.78
    p Value Comment
    One-sided significance level 0.05
    statistical Method
    t-test, 1 sided
  2. group Description
    Week 5
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.51
    p Value Comment
    One-sided significance level 0.05
    statistical Method
    t-test, 1 sided
  3. group Description
    Week 9
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.49
    p Value Comment
    One-sided significance level 0.05
    statistical Method
    t-test, 1 sided
  4. group Description
    Week 9
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.50
    p Value Comment
    One-sided significance level 0.05
    statistical Method
    t-test, 1 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.77
        value
        -0.44
      2. group Id
        OG001
        spread
        1.91
        value
        -0.17
      3. group Id
        OG002
        spread
        2.29
        value
        -0.16
    denoms
    1. counts
      1. group Id
        OG000
        value
        66
      2. group Id
        OG001
        value
        60
      3. group Id
        OG002
        value
        62
      units
      Participants
    title
    Week 5
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.68
        value
        -0.42
      2. group Id
        OG001
        spread
        1.86
        value
        -0.43
      3. group Id
        OG002
        spread
        2.39
        value
        -0.43
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        61
      3. group Id
        OG002
        value
        63
      units
      Participants
    title
    Week 9
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      74
    3. group Id
      OG002
      value
      77
    units
    Participants
description
The PHQ-4 is a brief screening questionnaire for depression. Possible scores range from 0 to 12, with higher scores indicating more severe depression. Change score is calculated by subtracting baseline from later score, with a negative change score indicating decreased severity of depression. This measure is referred to as "depressive mood" in the protocol.
dispersion Type
Standard Error
groups
  1. description
    One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
    id
    OG000
    title
    Bupropion 150 mg
  2. description
    One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
    id
    OG001
    title
    Bupropion 300 mg
  3. description
    One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
    id
    OG002
    title
    Placebo
param Type
MEAN
population Description
Eligible with baseline data
reporting Status
POSTED
time Frame
Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)
title
Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score ("Depressive Mood")
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice