Trial · NCT00705003
Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)
NCT00705003, Phase 2, Completed, Massachusetts General Hospital; results first posted 2014-06-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD). Trials, record NCT00705003. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00705003
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)
- NCT number
- NCT00705003
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 142 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Major Depressive Disorder
- Interventions
- BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD, BCI-024 (Buspirone), Matching placebo
- First posted
- 2008-06-25
- Last updated
- 2014-06-18
- Results first posted
- 2014-06-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6 | Week 6 | Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient's clinical condition and the severity of side effects experienced (Guy 1976). Specifically, it consists of two global subscales: Global Improvement (CGI-I) Severity of Illness (CGI-S) The CGI-I was administered at Weeks 2, 4 and 6. The CGI-I evaluation was performed with instruction to "Rate the patient's total improvement whether or not, in your judgment, it is due entirely to drug treatment." The Investigator was asked "Compared to the patient's condition at the Baseline visit, please assign a rating to how much the patient changed." Responses for the CGI-I evaluation included the following categories: 0: Not Assessed 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse |
| Secondary | The Change From Baseline in the CGI-S at Week 6 | Baseline and Week 6 | Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient's clinical condition and the severity of side effects experienced (Guy 1976). The CGI-S is a sub-scale of the Clinical Global Impression. The Investigator was asked: "Considering your total clinical experience with patients with this particular population, please assign a rating to how mentally ill the subject is at this time." Possible responses include the following: 0: Not Assessed 1. Normal, not ill at all 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients. The change from baseline CGI-S score was calculated as the baseline CGI-S score minus the post-baseline CGI-S score, such that a positive change indicated an improvement from baseline. |
| Secondary | The Change From Baseline in the IDS-C30 at Week 6 | Week 0 and Week 6 | The Inventory of Depressive Symptomatology is a 30-item scale that assesses criteria including mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep, decrease/increase in appetite or weight, psychomotor agitation or retardation, diurnal mood variation, capacity for pleasure, sexual interest, bodily aches and pains, panic or phobic symptoms, digestive problems, interpersonal rejection sensitivity, and leaden paralysis. Items are scored on a 4 point scale with 0 reflecting no symptoms and 3 reflecting symptoms of maximum severity. The total score is calculated by summing the scores from 28 of the 30 items. Only one of items 11 or 12, and only one of items 13 or 14 are scored. The minimum score is 0 and the maximum score is 84. A score of 84 indicates maximum severity of depressive symptoms. Change from baseline is calculated as the baseline score minus the post-baseline score. A positive change indicates improvement. |
| Secondary | The Change From Baseline in the Quick Inventory of Depressive Symptomatology - 16 Item Self-Report (QIDS-SR16) at Week 6 | Baseline and Week 6 | The QIDS-SR16 is a 16 question, patient rated scale that assesses the 9 Diagnostic \& Statistical Manual of Mental Disorders-IV-Text Revision criterion diagnostic symptom domains including sad mood, concentration, self criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, decrease or increase in appetite or weight, \& psychomotor agitation or retardation. Each item is measured on a scale of 0 to 3. To find total score, you enter: 1. highest score from items 1-4 (Sleep Items) 2. item 5 score 3. highest score from items 6-9 (appetite/weight) 4. item 10 score 5. item 11 score 6. item 12 score 7. item 13 score 8. item 14 score 9. highest score from items 15-16 (psychomotor) These 9 scores are summed to find total score. Total minimum score is 0 units on a scale \& total maximum score is 27 units, where higher scores indicate more severe depression. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement |
| Secondary | The Change From Baseline on the HAM-A at Week 6 | Week 0 and Week 6 | The 14-item HAM-A scale rates the patient's level of anxiety based on feelings of anxiousness, tension, and depression; any phobias, sleep disturbance, or difficulty in concentrating; the presence of genitourinary, cardiovascular, respiratory, autonomic or somatic symptoms; and the interviewer's assessment of the patient's appearance and behavior during the interview. Each item is to be scored on a 5 point scale with 0 reflecting no symptoms and 4 reflecting symptoms of maximum symptom severity (Hamilton 1960). The items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 56 units on a scale, where higher scores indicate more severe anxiety. Change from baseline is calculated as baseline score minus Week 6 score. A positive change indicates improvement. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6 | Week 6 | 142 subjects were enrolled and randomized in the study. 8 of these subjects were randomized but never received study drug. Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug. | units on a scale | MEAN |
| SECONDARY | The Change From Baseline in the CGI-S at Week 6 | Baseline and Week 6 | Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug. | units on a scale | MEAN |
| SECONDARY | The Change From Baseline in the IDS-C30 at Week 6 | Week 0 and Week 6 | Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug. | units on a scale | MEAN |
| SECONDARY | The Change From Baseline in the Quick Inventory of Depressive Symptomatology - 16 Item Self-Report (QIDS-SR16) at Week 6 | Baseline and Week 6 | Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug. | units on a scale | MEAN |
| SECONDARY | The Change From Baseline on the HAM-A at Week 6 | Week 0 and Week 6 | Efficacy analysis were completed for the MITT Population: Subjects included in the MITT analysis received at least 1 dose of study drug and provided at least 1 post-baseline CGI-I assessment. Subjects included in the analysis of safety received at least 1 dose of study drug. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6 | BCI-024+BCI-049 | 2.37 | Standard Error 0.97 | units on a scale | |
| The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6 | BCI-024 | 2.82 | Standard Error 1.24 | units on a scale | |
| The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6 | Placebo | 2.86 | Standard Error 1.09 | units on a scale | |
| The Change From Baseline in the CGI-S at Week 6 | BCI-024 and BCI-049 | 1.43 | Standard Deviation 1.08 | units on a scale | |
| The Change From Baseline in the CGI-S at Week 6 | BCI-024 | .93 | Standard Deviation 1.07 | units on a scale | |
| The Change From Baseline in the CGI-S at Week 6 | Placebo | 0.97 | Standard Deviation 1.16 | units on a scale | |
| The Change From Baseline in the IDS-C30 at Week 6 | BCI-024 and BCI-049 | 19.24 | Standard Error 1.60 | units on a scale | |
| The Change From Baseline in the IDS-C30 at Week 6 | BCI-024 | 16.35 | Standard Error 2.22 | units on a scale | |
| The Change From Baseline in the IDS-C30 at Week 6 | Placebo | 14.42 | Standard Error 2.14 | units on a scale | |
| The Change From Baseline in the Quick Inventory of Depressive Symptomatology - 16 Item Self-Report (QIDS-SR16) at Week 6 | BCI-024 and BCI-049 | 8.57 | Standard Error 0.66 | units on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Enrolled | STARTED | BCI-024 and BCI-049 (Buspirone and Melatonin) | 71 | |
| Enrolled | STARTED | BCI-024 (Buspirone) | 37 | |
| Enrolled | STARTED | Placebo | 34 | |
| Enrolled | COMPLETED | BCI-024 and BCI-049 (Buspirone and Melatonin) | 67 | |
| Enrolled | COMPLETED | BCI-024 (Buspirone) | 34 | |
| Enrolled | COMPLETED | Placebo | 33 | |
| Enrolled | NOT COMPLETED | BCI-024 and BCI-049 (Buspirone and Melatonin) | 4 | |
| Enrolled | NOT COMPLETED | BCI-024 (Buspirone) | 3 | |
| Enrolled | NOT COMPLETED | Placebo | 1 | |
| Treated | STARTED | BCI-024 and BCI-049 (Buspirone and Melatonin) | 67 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events12
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 | Diarrhea | Gastrointestinal disorders | BCI-024 and BCI-049 | 6 | 67 | 6 |
| other | Diarrhea | Gastrointestinal disorders | BCI-024 | 1 | 34 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 2 | 33 | 2 |
| other | Constipation | Gastrointestinal disorders | BCI-024 and BCI-049 | 1 | 67 | 1 |
| other | Constipation | Gastrointestinal disorders | BCI-024 | 2 | 34 | 2 |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 33 | 0 |
| other | Dizziness | Nervous system disorders | BCI-024 and BCI-049 | 4 | 67 | 4 |
| other | Dizziness | Nervous system disorders | BCI-024 | 1 | 34 | 1 |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 33 | 0 |
| other | Headache | Nervous system disorders | BCI-024 and BCI-049 | 5 | 67 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BCI-024 and BCI-049 | ||
| Total, all-cause mortality | BCI-024 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | BCI-024 and BCI-049 | 16 | 67 |
| Total, other adverse events | BCI-024 | 7 | 34 |
| Total, other adverse events | Placebo | 4 | 33 |
| Total, serious adverse events | BCI-024 and BCI-049 | 0 | 67 |
| Total, serious adverse events | BCI-024 | 0 | 34 |
| Total, serious adverse events | Placebo | 0 | 33 |
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/NCT00705003
GET https://conductscience.org/api/trials/v1/NCT00705003/registered