Trial · NCT00296725
Dichotic Listening as a Predictor of Medication Response in Depression
NCT00296725, Phase 1, Phase 2, Completed, New York State Psychiatric Institute; results first posted 2019-05-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dichotic Listening as a Predictor of Medication Response in Depression. Trials, record NCT00296725. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00296725
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dichotic Listening as a Predictor of Medication Response in Depression
- NCT number
- NCT00296725
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- New York State Psychiatric Institute
- Conditions
- Major Depression, Dysthymia, Depressive Disorder Not Otherwise Specified
- Interventions
- Fluoxetine, Imipramine
- First posted
- 2006-02-27
- Last updated
- 2019-05-30
- Results first posted
- 2019-05-15
- Limitations and caveats
- Open, non-randomized treatment and ratings; small sample size
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hamilton Depression Scale (HAM-D) | 6 weeks | The HAM-D is a commonly used measure of the severity of depression. While several versions exist consisting of different numbers of items, virtually all include the original 17. Each item is scored from on a 3 or 5 point scale (so, from 0-2 or 0-4), with 0 indicating the item is not present and the highest item score indicating it is present nearly all the time to the severest extent. Item scores are added to obtain a total HAM-D score. Minimum possible score is 0 (indicating none of the 17 items is present), maximal possible score is 52. By convention, scores of \<=7 are accepted as indicating "remission" and scores that have decreased \>= 50% from pre-treatment indicate positive "response". Higher scores indicate worse depression, while lower scores indicate milder depression or lack of depressive symptoms. |
| Secondary | Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I) | 6 weeks. | The CGI consists of two ratings: 1) Global Severity (CGI-S) and 2) Global Improvement (CGI-I), both having seven possible ratings, each from 1-7. Ratings on the CGI-S are: 1="No psychopathology" 2="Minimal psychopathology" 3="Mild psychopathology 4="Moderate psychopathology" 5="Moderately severe psychopathology" 6="Severe psychopathology" 7 "Extreme psychopathology". CGI-I ratings are rated for how the past week's psychopathology compares to the week immediately prior to start of treatment and includes: 1="Very much improved" 2="much improved" 3="minimally improved" 4="Unchanged" 5="minimally worse" 6="much worse" 7="very much worse". Scores on both thus range from 1-7 with lower scores indicating less psychopathology/greater improvement, respectively, and higher scores indicating more psychopathology/less improvement, respectively. We define "response" as a CGI-I of 1 or 2; "nonresponse" is all other ratings (i.e., CGI-I = 3 or higher. |
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 | Hamilton Depression Scale (HAM-D) | 6 weeks | score on a scale | MEAN | |
| SECONDARY | Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I) | 6 weeks. | Response Rate | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hamilton Depression Scale (HAM-D) | Fluoxetine | 10 | Standard Deviation 7 | score on a scale | |
| Hamilton Depression Scale (HAM-D) | Imipramine | 9 | Standard Deviation 7 | score on a scale | |
| Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I) | Fluoxetine | 7 | Participants | ||
| Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I) | Imipramine | 4 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1: Fluoxetine (1-12 Weeks) | STARTED | Fluoxetine / Imipramine | 17 | |
| Phase 1: Fluoxetine (1-12 Weeks) | COMPLETED | Fluoxetine / Imipramine | 12 | |
| Phase 1: Fluoxetine (1-12 Weeks) | NOT COMPLETED | Fluoxetine / Imipramine | 5 | |
| Phase 2: Imipramine (1-6 Weeks) | STARTED | Fluoxetine / Imipramine | 8 | |
| Phase 2: Imipramine (1-6 Weeks) | COMPLETED | Fluoxetine / Imipramine | 7 | |
| Phase 2: Imipramine (1-6 Weeks) | NOT COMPLETED | Fluoxetine / Imipramine | 1 |
Source ClinicalTrials.gov
Adverse events8
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 | shortness of breath | Respiratory, thoracic and mediastinal disorders | Fluoxetine | 1 | 17 | 1 |
| other | shortness of breath | Respiratory, thoracic and mediastinal disorders | Imipramine | 0 | 8 | 0 |
| other | irritability | Psychiatric disorders | Fluoxetine | 1 | 17 | 1 |
| other | irritability | Psychiatric disorders | Imipramine | 0 | 8 | 0 |
| other | rash | Immune system disorders | Fluoxetine | 2 | 17 | 2 |
| other | rash | Immune system disorders | Imipramine | 0 | 8 | 0 |
| other | lost to follow-up | General disorders | Fluoxetine | 3 | 17 | 3 |
| other | lost to follow-up | General disorders | Imipramine | 1 | 8 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluoxetine | 0 | 17 |
| Total, all-cause mortality | Imipramine | 0 | 8 |
| Total, other adverse events | Fluoxetine | 7 | 17 |
| Total, other adverse events | Imipramine | 1 | 8 |
| Total, serious adverse events | Fluoxetine | 0 | 17 |
| Total, serious adverse events | Imipramine | 0 | 8 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Fluoxetine vs Imipramine: Number of Participants With Positive Response as Assessed by the Clinical Global Impression -Global Improvement Scale (CGI-I) | Trial comparisons |
| Fluoxetine vs Imipramine: deaths from any cause | Trial comparisons |
| Fluoxetine vs Imipramine: 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.
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/NCT00296725
GET https://conductscience.org/api/trials/v1/NCT00296725/registered