Trial · NCT00668525
Escitalopram in Adult Patients With Major Depressive Disorder
NCT00668525, Phase 3, Completed, Forest Laboratories; results first posted 2010-05-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Escitalopram in Adult Patients With Major Depressive Disorder. Trials, record NCT00668525. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00668525
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Escitalopram in Adult Patients With Major Depressive Disorder
- NCT number
- NCT00668525
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 877 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Major Depressive Disorder
- Interventions
- Escitalopram, Placebo, Escitalopram
- First posted
- 2008-04-29
- Last updated
- 2010-05-11
- Results first posted
- 2010-05-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks. | Change from baseline in MADRS total score at week 8 | The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms). |
| Secondary | Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8 | Change from baseline in HAM-D at week 8 | The HAMD is a clinician-rated 24-item scale was used to rate the patient's depressive state. It was also used to identify obsessive-compulsive, genital, and somatic symptoms, as well as diurnal variation in the presence of symptoms. Each item was scored on a 3, 4 or 5-point Likert scale. A score of 0 indicated the absence of symptoms, and a score of 2, 3 or 4 indicated symptoms of maximum severity. The total score range is 0 to 74 (higher score indicates a greater depressive state). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks. | Change from baseline in MADRS total score at week 8 | The analysis was performed on the intent to treat population based on the LOCF approach using an ANCOVA model with treatment group and study center as factors and the baseline MADRS total score as a covariate. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8 | Change from baseline in HAM-D at week 8 | The analysis was performed on the intent to treat population based on the LOCF approach using an ANCOVA model with treatment group and study center as factors and the baseline HAMD total score as a covariate. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks. | Escitalopram Low Dose | -12.8 | Standard Error 0.6 | Units on a scale | |
| Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks. | Escitalopram High Dose | -13.4 | Standard Error 0.6 | Units on a scale | |
| Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks. | Placebo | -10.1 | Standard Error 0.7 | Units on a scale | |
| Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8 | Escitalopram Low Dose | -11.5 | Standard Error 0.5 | Units on a scale | |
| Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8 | Escitalopram High Dose | -11.6 | Standard Error 0.6 | Units on a scale | |
| Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8 | Placebo | -8.5 | Standard Error 0.6 | Units on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Escitalopram Low Dose | 325 | |
| Overall Study | STARTED | Escitalopram High Dose | 332 | |
| Overall Study | STARTED | Placebo | 220 | |
| Overall Study | COMPLETED | Escitalopram Low Dose | 248 | |
| Overall Study | COMPLETED | Escitalopram High Dose | 239 | |
| Overall Study | COMPLETED | Placebo | 167 | |
| Overall Study | NOT COMPLETED | Escitalopram Low Dose | 77 | |
| Overall Study | NOT COMPLETED | Escitalopram High Dose | 93 | |
| Overall Study | NOT COMPLETED | Placebo | 53 |
Source ClinicalTrials.gov
Adverse events63
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 | Escitalopram Low Dose | 52 | 322 | |
| other | Headache | Nervous system disorders | Escitalopram High Dose | 45 | 324 | |
| other | Headache | Nervous system disorders | Placebo | 31 | 218 | |
| other | Nausea | Gastrointestinal disorders | Escitalopram Low Dose | 41 | 322 | |
| other | Nausea | Gastrointestinal disorders | Escitalopram High Dose | 37 | 324 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 16 | 218 | |
| other | Diarrhea | Gastrointestinal disorders | Escitalopram Low Dose | 30 | 322 | |
| other | Diarrhea | Gastrointestinal disorders | Escitalopram High Dose | 35 | 324 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 14 | 218 | |
| other | Insomnia | Psychiatric disorders | Escitalopram Low Dose | 19 | 322 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Escitalopram Low Dose | ||
| Total, all-cause mortality | Escitalopram High Dose | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Escitalopram Low Dose | 146 | 322 |
| Total, other adverse events | Escitalopram High Dose | 160 | 324 |
| Total, other adverse events | Placebo | 74 | 218 |
| Total, serious adverse events | Escitalopram Low Dose | 3 | 322 |
| Total, serious adverse events | Escitalopram High Dose | 7 | 324 |
| Total, serious adverse events | Placebo | 4 | 218 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT00668525
GET https://conductscience.org/api/trials/v1/NCT00668525/events?page=2