Trial · NCT01312922
Pipamperone/Citalopram (PNB01) Versus Citalopram (CIT) and Versus Pipamperone (PIP) in Major Depressive Disorder (MDD)
NCT01312922, Phase 3, Completed, PharmaNeuroBoost N.V.; results first posted 2022-04-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pipamperone/Citalopram (PNB01) Versus Citalopram (CIT) and Versus Pipamperone (PIP) in Major Depressive Disorder (MDD). Trials, record NCT01312922. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01312922
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pipamperone/Citalopram (PNB01) Versus Citalopram (CIT) and Versus Pipamperone (PIP) in Major Depressive Disorder (MDD)
- NCT number
- NCT01312922
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 555 participants, actual
- Lead sponsor
- PharmaNeuroBoost N.V.
- Conditions
- Major Depressive Disorder
- Interventions
- PNB01 fixed dose combination of pipamperone and citalopram, Citalopram, Pipamperone
- First posted
- 2011-03-11
- Last updated
- 2022-04-07
- Other registries' IDs
- eudract:2011-001190-11
- Results first posted
- 2022-04-07
- Limitations and caveats
To avoid limited risk of concluding efficacy when there is no effect, hierarchical testing was implemented with following order of confirmatory tests: 1) Patient-ESR rates of PNB01vs citalopram 2) If above testing is sig., repeat patient-ESR testing for PNB01vs pipamperone 3) In case in 1 of these 2 tests PNB01 does not have sig. higher ESR rate, trial is considered negative, \& no following sec. confirmatory tests are to be executed.~Secondary Outcome Measures were therefore not completed
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Early and Sustained (Antidepressant) Response (ESR) Rate | From (end of) Week 2 visit to (end of) Week 6 visit | Early and Sustained Response (ESR) is defined as a MADRS total score reduction from Baseline of 50% or more and a MADRS total score ≤16 at Week 2, Week 3, Week 4, and Week 6. |
| Secondary | Change From Baseline in Total MADRS Score at Week 6 | From Baseline (Day 1) to (end of) Week 6 | Change from baseline in total score on the Montgomery-Asberg Depression Rating Scale (MADRS) after 6 weeks of study treatment as assessed by the patient using an Interactive Voice Response System (IVRS) via telephone The MADRS scale is a widely used and well-validated 10-item diagnostic questionnaire designed to measure the severity of depressive episodes in patients with mood disorders. The 10 items are all rated on a scale from 0 to 6 (resulting in a maximum total score of 60 points) and include 'apparent sadness', 'reported sadness', 'inner tension', 'reduced sleep', 'reduced appetite', 'concentration difficulties', 'lassitude', 'inability to feel', 'pessimistic thoughts' and 'suicidal thoughts'. Higher scores indicative of greater depressive symptomology. |
| Secondary | Change From Baseline in Total SDS Score at Week 6 | From Baseline (Day 1) to (end of) Week 6 visit | Change from baseline in total score on the Sheehan Disability Scale (SDS) after 6 weeks of study treatment as assessed by the patient using an Interactive Voice Response System (IVRS) via telephone The SDS is a generic brief self-report tool that was developed to assess functional impairment in three inter-related domains; 1) work or school, 2) social life and 3) family life. The patient rates the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. Total scores range from a minimum of 0 to a maximum of 30 (0 unimpaired, 30 highly impaired). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Early and Sustained (Antidepressant) Response (ESR) Rate | From (end of) Week 2 visit to (end of) Week 6 visit | Full Analysis Set (FAS): The FAS consists of all patients who are randomized and were administered at least one dose of trial medication, as assessed from pill counting. Patients will be analyzed according to the treatment group to which they were randomized (intention-to-treat principle), irrespective of the study treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Total MADRS Score at Week 6 | From Baseline (Day 1) to (end of) Week 6 | Secondary Outcome Measures were pre-specified to be completed based on significance of the Primary Outcome Measure. Secondary Outcome Measures were therefore not completed. | ||
| SECONDARY | Change From Baseline in Total SDS Score at Week 6 | From Baseline (Day 1) to (end of) Week 6 visit | Secondary Outcome Measures were pre-specified to be completed based on significance of the Primary Outcome Measure. Secondary Outcome Measures were therefore not completed. |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Early and Sustained (Antidepressant) Response (ESR) Rate | PNB01 | 17 | Participants | ||
| Early and Sustained (Antidepressant) Response (ESR) Rate | Citalopram | 17 | Participants | ||
| Early and Sustained (Antidepressant) Response (ESR) Rate | Pipamperone | 17 | Participants |
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 | PNB01 | 185 | |
| Overall Study | STARTED | Citalopram | 185 | |
| Overall Study | STARTED | Pipamperone | 185 | |
| Overall Study | COMPLETED | PNB01 | 117 | |
| Overall Study | COMPLETED | Citalopram | 131 | |
| Overall Study | COMPLETED | Pipamperone | 135 | |
| Overall Study | NOT COMPLETED | PNB01 | 68 | |
| Overall Study | NOT COMPLETED | Citalopram | 54 | |
| Overall Study | NOT COMPLETED | Pipamperone | 50 |
Source ClinicalTrials.gov
Adverse events72
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 | Diarrhoea | Gastrointestinal disorders | PNB01 | 9 | 185 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Citalopram | 17 | 185 | 19 |
| other | Diarrhoea | Gastrointestinal disorders | Pipamperone | 1 | 185 | 1 |
| other | Dry Mouth | Gastrointestinal disorders | PNB01 | 18 | 185 | 18 |
| other | Dry Mouth | Gastrointestinal disorders | Citalopram | 10 | 185 | 11 |
| other | Dry Mouth | Gastrointestinal disorders | Pipamperone | 16 | 185 | 17 |
| other | Nausea | Gastrointestinal disorders | PNB01 | 16 | 185 | 17 |
| other | Nausea | Gastrointestinal disorders | Citalopram | 28 | 185 | 30 |
| other | Nausea | Gastrointestinal disorders | Pipamperone | 14 | 185 | 16 |
| other | Dizziness | Nervous system disorders | PNB01 | 10 | 185 | 13 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PNB01 | 0 | 185 |
| Total, all-cause mortality | Citalopram | 0 | 185 |
| Total, all-cause mortality | Pipamperone | 0 | 185 |
| Total, other adverse events | PNB01 | 127 | 185 |
| Total, other adverse events | Citalopram | 131 | 185 |
| Total, other adverse events | Pipamperone | 118 | 185 |
| Total, serious adverse events | PNB01 | 3 | 185 |
| Total, serious adverse events | Citalopram | 4 | 185 |
| Total, serious adverse events | Pipamperone | 1 | 185 |
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/NCT01312922
GET https://conductscience.org/api/trials/v1/NCT01312922/events?page=2