Trial · NCT00733980
A Study of the Effects of a New Antidepressant Treatment (GSK561679) in Females With Major Depressive Disorder
NCT00733980, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-11-17
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study of the Effects of a New Antidepressant Treatment (GSK561679) in Females With Major Depressive Disorder. Trials, record NCT00733980. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00733980
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Effects of a New Antidepressant Treatment (GSK561679) in Females With Major Depressive Disorder
- NCT number
- NCT00733980
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 150 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Depressive Disorder, Major
- Interventions
- GSK561679, Placebo
- First posted
- 2008-08-13
- Last updated
- 2017-11-17
- Results first posted
- 2017-11-17
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Randomization to the End of Treatment Phase (Week 6) in the Bech Melancholia Subscale (Bech) (Items 1, 2, 7, 8, 10 and 13) From the Hamilton Rating Scale for Depression (HamD17). | Randomization (Week 0) and Week 6 | The Bech Melancholia Sub-scale is extracted from the HAMD-17 and is comprised of the following 6 items: Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic, and Somatic Symptoms General. The items Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic are scored on a 5-point scale from 0 to 4 except for Somatic Symptoms General which is scored on a 3-point scale from 0 to 2 where the higher scores reflecting greater severity. The Bech Melancholia Scale total score is calculated by summing the individual response scores. The highest possible score is 22 (indicative of greater severity) and the lowest possible score is 0 (indicating absence of symptoms). Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0. |
| Secondary | Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score. | Randomization (Week 0) and Week 1, 2 and 4 | The Bech Melancholia Sub-scale is extracted from the HAMD-17 and is comprised of the following 6 items: Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic, and Somatic Symptoms General. The items Depressed Mood, Feelings of Guilt, Work and Activities, Retardation, Anxiety Psychic are scored on a 5-point scale from 0 to 4 except for Somatic Symptoms General which is scored on a 3-point scale from 0 to 2 where the higher scores reflecting greater severity. The Bech Melancholia Scale total score is calculated by summing the individual response scores. The highest possible score is 22 (indicative of greater severity) and the lowest possible score is 0 (indicating absence of symptoms). Change from randomization was defined as the post-baseline value minus the value post randomization (Weeks 1, 2 and 4). Randomization was defined as Week 0. |
| Secondary | Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A) | Randomization (Week 0) and Week 1, 2, 4 and Week 6 | HAM A, is internationally accepted and validated measurement tool for assessment of severity of anxiety symptoms. Used to assess severity of overall anxiety in participants who met criteria for anxiety of depressive disorders and to monitor outcome of treatment. Instrument does not distinguish symptoms of specific anxiety disorder or distinguish an anxiety disorder from an anxious depression. It is clinician-administered and consists of 14 individual questions, each rated on five point scale from 0 (not present) to 4 (very severe). Total HAM A range from 0 to 56 with higher scores reflecting more severe anxiety. Change from randomization was defined as post-baseline value minus value at randomization. Randomization was defined as Week 0. Provided no more than 1 response was missing for any one visit assessment for a participant, total score was calculated adjusting for missing data as follows: Total score = (14/13)\* observed total score the score was rounded to nearest integer number. |
| Secondary | Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score. | Randomization (Week 0) and Week 1, 2, 3,4 and Week 6 | The IDS-SR is self-report rating scale that assesses symptom severity of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), diagnostic criterion for major depressive disorder. The IDS-SR is a 30 item self report used to assess the severity of depressive symptoms. Each item has a 4-likert scale and each symptom item is given equivalent weightings and scored on 0 to 3 scale, with 3 representing the worst symptom. The total score of IDS-SR is calculated as a sum of each item score. The range of possible score is between 0 and 90, 0 as no symptom and 90 the worst symptom. The higher the score, the more severe the depression. Change from randomization was defined as the post-baseline value minus the value post randomization (Weeks 1, 2,3, 4 and 6). Randomization was defined as Week 0. |
| Secondary | Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17) | Randomization (Week 0) and Week 1, 2, 4 and Week 6 | The HAMD-17 scale is a subset of HAMD-28. It is a standard used to measure depression severity. The HAMD-17 score ranges from 0 to 52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity; a reduction of 50% or more in total score from Baseline indicates clinical response. Thus a higher score was indicative of more severity. Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0. |
| Secondary | Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6. | Weeks 1, 2, 4, and 6. | HAMD-17 Responders were defined as the participants with a \> or = 50% reduction from randomization in their HAMD-17 total score at Weeks 1, 2, 4, and 6. The HAMD-17 scale is a subset of HAMD-28. It is a standard used to measure depression severity. The HAMD-17 score ranged from 0 to 52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicated at least moderate severity; a reduction of 50% or more in total score from Baseline indicates clinical response. Thus a higher score was indicative of more severity. |
| Secondary | Time to Maintained Antidepressant Response at the End of Treatment Phase (Week 6) | Week 6 | The time to maintained antidepressant response at the end of treatment phase (week 6), as the participants with a \> or = to 50 % reduction from randomization in their HAMD-17 total score, sustained until the end of the Treatment Phase \[Week 6\]). This OM "time to maintained antidepressant response" was not evaluated due to lower number of participants in the GSK561679 group as compared to placebo |
| Secondary | Change From Randomization in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 4, and 6. | Randomization (Week 0) and Weeks 1, 2, 4, and 6. | The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. The CGI is psychiatrist rated, and is based on all information available at the time of the rating. Both the CGI-I and CGI-S items are rated on a 1 to 7 point scale. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). Scores, on the CGI-S, range from 1 (normal, not ill at all) to 7 (amongst the most extremely ill). Change from randomization was defined as the post-baseline value minus the value at randomization. Randomization was defined as Week 0. |
| Secondary | Percentage of Clinical Global Impression - Global Improvement (CGI-I) Responders at Weeks 1, 2, 4, and 6. | Weeks 1, 2, 4, and 6. | The CGI is a widely accepted measure of illness severity and clinical improvement in a variety of psychiatric disorders. The CGI is psychiatrist rated, and is based on all information available at the time of the rating. The CGI -responders, are defined as participants with a score of 1 (very much improved) or 2 (much improved) in the CGI-I). |
| Secondary | Change From Randomization in the Medical Outcomes Study 12-item Sleep Module (MOS 12) at Week 6 | Randomization (Week 0) and Week 6 | The MOS-12 Sleep Scale is a 12-item questionnaire which measures specific aspects of sleep in participants that may have varying co-morbidities, as a result, is appropriate for a medically diverse participant population. It consist of following items: initiation (2 items), maintenance (2 items), respiratory problems (2 items), quantity (1 item), perceived adequacy (2 items), and somnolence (3 items). All items were given equivalent weightage from 1 to 6. Each index summarizes information across most or all sleep dimensions. The total score is transformed linearly to a common metric with a possible range of 0-100 and is averaged across items in the same scale. The higher score indicates a greater degree of the attribute implied by the scale name. Change from randomization was calculated by randomization value minus the value at Week 6. Randomization was defined as Week 0. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Randomization to the End of Treatment Phase (Week 6) in the Bech Melancholia Subscale (Bech) (Items 1, 2, 7, 8, 10 and 13) From the Hamilton Rating Scale for Depression (HamD17). | Randomization (Week 0) and Week 6 | Intent to Treat (ITT) population consisted of all participants who gave informed consent, were randomized, received at least one dose of double-blind medication, and had at least one post-randomization efficacy assessment available (HAM D, IDS-SR CGI, HAM A, MOS, PSS). | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score. | Randomization (Week 0) and Week 1, 2 and 4 | ITT population. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A) | Randomization (Week 0) and Week 1, 2, 4 and Week 6 | ITT population. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score. | Randomization (Week 0) and Week 1, 2, 3,4 and Week 6 | ITT population | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17) | Randomization (Week 0) and Week 1, 2, 4 and Week 6 | ITT population. | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6. | Weeks 1, 2, 4, and 6. | ITT population. Only those participants available at the specified time points were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Time to Maintained Antidepressant Response at the End of Treatment Phase (Week 6) | Week 6 | Endpoint not evaluated. | ||
| SECONDARY | Change From Randomization in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 4, and 6. | Randomization (Week 0) and Weeks 1, 2, 4, and 6. | ITT population | Scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Clinical Global Impression - Global Improvement (CGI-I) Responders at Weeks 1, 2, 4, and 6. | Weeks 1, 2, 4, and 6. | perecntage of participants | NUMBER | |
| SECONDARY | Change From Randomization in the Medical Outcomes Study 12-item Sleep Module (MOS 12) at Week 6 | Randomization (Week 0) and Week 6 | ITT population. | Scores on scale | LEAST_SQUARES_MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group1,324
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Randomization to the End of Treatment Phase (Week 6) in the Bech Melancholia Subscale (Bech) (Items 1, 2, 7, 8, 10 and 13) From the Hamilton Rating Scale for Depression (HamD17). | GSK561679 | -4.3150 | Standard Error 0.5314 | Scores on scale | |
| Change From Randomization to the End of Treatment Phase (Week 6) in the Bech Melancholia Subscale (Bech) (Items 1, 2, 7, 8, 10 and 13) From the Hamilton Rating Scale for Depression (HamD17). | Placebo | -4.5629 | Standard Error 0.5101 | Scores on scale | |
| Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score. | GSK561679 | Week 1 | -1.6739 | Standard Error 0.3886 | Scores on scale |
| Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score. | Placebo | Week 1 | -1.6570 | Standard Error 0.3540 | Scores on scale |
| Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score. | GSK561679 | Week 2 | -2.6200 | Standard Error 0.4436 | Scores on scale |
| Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score. | Placebo | Week 2 | -3.0499 | Standard Error 0.4106 | Scores on scale |
| Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score. | GSK561679 | Week 4 | -3.1318 | Standard Error 0.4798 | Scores on scale |
| Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score. | Placebo | Week 4 | -4.0731 | Standard Error 0.4526 | Scores on scale |
| Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A) | GSK561679 | Week 1 | -3.4188 | Standard Error 0.7432 | Scores on scale |
| Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A) | Placebo | Week 1 | -4.3683 | Standard Error 0.6649 | Scores on scale |
1 to 10 of 1,324Source ClinicalTrials.gov
See all 1,324 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSK561679 | 74 | |
| Overall Study | STARTED | Placebo | 76 | |
| Overall Study | COMPLETED | GSK561679 | 52 | |
| Overall Study | COMPLETED | Placebo | 55 | |
| Overall Study | NOT COMPLETED | GSK561679 | 22 | |
| Overall Study | NOT COMPLETED | Placebo | 21 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | GSK561679 | 9 | 74 | 9 |
| other | Headache | Nervous system disorders | Placebo | 17 | 76 | 19 |
| other | Nausea | Gastrointestinal disorders | GSK561679 | 15 | 74 | 18 |
| other | Nausea | Gastrointestinal disorders | Placebo | 10 | 76 | 10 |
| other | Nasopharyngitis | Infections and infestations | GSK561679 | 6 | 74 | 6 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 5 | 76 | 5 |
| other | Dry mouth | Gastrointestinal disorders | GSK561679 | 5 | 74 | 5 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 5 | 76 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | GSK561679 | 3 | 74 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 76 | 5 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK561679 | 0 | 74 |
| Total, all-cause mortality | Placebo | 0 | 76 |
| Total, other adverse events | GSK561679 | 34 | 74 |
| Total, other adverse events | Placebo | 44 | 76 |
| Total, serious adverse events | GSK561679 | 0 | 74 |
| Total, serious adverse events | Placebo | 1 | 76 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GSK561679 vs Placebo: Number of Participants With Abnormal Hematology Values of PCI-Platelet | Trial comparisons |
| GSK561679 vs Placebo: deaths from any cause | Trial comparisons |
| GSK561679 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00733980
GET https://conductscience.org/api/trials/v1/NCT00733980/results?page=2