DepressionPhase 2NCT00672659
Pipamperone/Citalopram (PipCit)Versus Citalopram in the Treatment of Major Depressive Disorder(MDD)
A Phase 2 study testing Citalopram + Pipamperone and Citalopram in people with Depression, run by PharmaNeuroBoost N.V. at 1 site in United Kingdom.
Trial summary
The primary objective is to demonstrate whether the addition of pipamperone 5 mg twice daily (bd) to citalopram, 40 mg daily in patients suffering from MDD will improve the efficacy of citalopram 40 mg in these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Citalopram + Pipamperone and Citalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients
- 18-65 years inclusive
- Suffering from a moderate to severe MDD as defined by DSM IV with an existence of depressed mood and loss of interest/anhedonia for at least four weeks and no longer than six months for the current episode
- Diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI) version 5.0.0.
- Clinical global impression - severity scale (CGI-S) rating of at least four and a minimum Hamilton Depression Scale (HAM-D) 17 items total score of 18 at screen and baseline
- A non-psychotic state
- Where appropriate, male patients should agree to use barrier contraceptive measures (condoms) during the course of the study and for three months after the last dose of medication
Who cannot join
- Premenopausal females not using adequate contraceptive measures
- Considered by the investigator to be a significant risk of suicide or scoring 5 or more on the MADRS question 10
- Significant other psychiatric illness which would interfere with trial assessments - co-morbid generalised anxiety disorder (GAD) and panic disorder will be permitted where MDD is considered the primary diagnosis
- Significant physical illness which would interfere with trial assessments
- Reduced hepatic function
- Epilepsy
Show all 14Show fewer
- History of cardiac dysrhythmia
- Alcohol intake above accepted UK ranges
- Recent (1 week) antidepressant (except for fluoxetine - 4 weeks and St John's Wort or MAOI's - 14 days), benzodiazepine or any other psychotropic medication ingestion including lithium or other mood stabilisers
- Resistant depression defined as having failed to respond to
- Two previous antidepressants at an adequate dose ingested for at least 4 weeks during the current episode
- To an augmentation therapy with an atypical antipsychotic drug
- Electroconvulsive therapy (ECT) for the current episode
- Formal psychotherapy or alternative treatments for one week prior to or during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IIa Proof of Concept Study of Pipamperone/Citalopram (PipCit) Versus Citalopram in the Treatment of Major Depressive Disorder (MDD)
The primary objective is to demonstrate whether the addition of pipamperone 5 mg twice daily (bd) to citalopram, 40 mg daily in patients suffering from MDD will improve the efficacy of citalopram 40 mg in these patients.
Secondary objectives are to demonstrate whether the addition of pipamperone 5 mg twice daily (bd) to citalopram, 40 mg daily in patients suffering from MDD:
Read more
- Will increase the rate of resolution of symptoms with citalopram 40 mg.
- Show the combined product to be safe and tolerable.
Patients are scheduled to receive study medication for eight weeks and a final follow-up check will be carried out 28 days after completing the study.
All patients will receive active citalopram from baseline and will be randomised to receive either active pipamperone or a placebo equivalent for eight weeks during which time they will attend for 6 study visits.
- Conditions
- Depression
- Being tested
- Citalopram + Pipamperone, Citalopram
- Keywords
- Lost of interest, Depressed Mood
- Medical subject headings
- Depression, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citalopram + PipamperoneDrug
Citalopram, 40 mg daily, 8 weeks Pipamperone, 5 mg twice daily, 8 weeks
CitalopramDrug
Citalopram, 40 mg daily, 8 weeks Placebo, dummy, twice a day, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Citalopram, 40 mg daily in combination with Pipamperone, 5 mg twice daily (bd) Receives: Drug: Citalopram + Pipamperone |
| 2 | Placebo comparator | Citalopram, 40 mg daily in combination with Placebo, dummy twice daily (bd) Receives: Drug: Citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Asberg Depression Rating Scale score
Measured: 8 weeks
Secondary outcomes (1)
The number of patients showing evidence of onset of action defined as a 20% improvement from baseline MADRS
Measured: At Weeks 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaNeuroBoost N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Erik Buntinx, MD, Study chair, PharmaNeuroBoost N.V.Alan Wade, MG, Study director, CPSResearchGordon Crawford, MD, Principal investigator, CPSResearch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672659
- Sponsor's protocol ID
- PNB/CPS 02 2007
- Status last verified
- Apr 2011
- First submitted
- 2 May 2008
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wade AG, Crawford GM, Nemeroff CB, Schatzberg AF, Schlaepfer T, McConnachie A, Haazen L, Buntinx E. Citalopram plus low-dose pipamperone versus citalopram plus placebo in patients with major depressive disorder: an 8-week, double-blind, randomized study on magnitude and timing of clinical response. Psychol Med. 2011 Oct;41(10):2089-97. doi: 10.1017/S0033291711000158. Epub 2011 Feb 25.
PubMed 21349239
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Proof of Concept Study of Pipamperone/Citalopram (PipCit) Versus Citalopram in the Treatment of Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT00672659
- Acronym / sponsor ID
- PNB/CPS 02 2007
- Conditions
- Depression
- Keywords
- Lost of interest, Depressed Mood
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- PharmaNeuroBoost N.V.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to demonstrate whether the addition of pipamperone 5 mg twice daily (bd) to citalopram, 40 mg daily in patients suffering from MDD will improve the efficacy of citalopram 40 mg in these patients.
Secondary objectives are to demonstrate whether the addition of pipamperone 5 mg twice daily (bd) to citalopram, 40 mg daily in patients suffering from MDD:
- Will increase the rate of resolution of symptoms with citalopram 40 mg.
- Show the combined product to be safe and tolerable.
Patients are scheduled to receive study medication for eight weeks and a final follow-up check will be carried out 28 days after completing the study.
All patients will receive active citalopram from baseline and will be randomised to receive either active pipamperone or a placebo equivalent for eight weeks during which time they will attend for 6 study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Citalopram + PipamperoneCitalopram, 40 mg daily in combination with Pipamperone, 5 mg twice daily (bd) |
| 2 | Placebo comparator | Drug: CitalopramCitalopram, 40 mg daily in combination with Placebo, dummy twice daily (bd) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients
- 18-65 years inclusive
- Suffering from a moderate to severe MDD as defined by DSM IV with an existence of depressed mood and loss of interest/anhedonia for at least four weeks and no longer than six months for the current episode
- Diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI) version 5.0.0.
- Clinical global impression - severity scale (CGI-S) rating of at least four and a minimum Hamilton Depression Scale (HAM-D) 17 items total score of 18 at screen and baseline
Key exclusion criteria (14 listed)
- Premenopausal females not using adequate contraceptive measures
- Considered by the investigator to be a significant risk of suicide or scoring 5 or more on the MADRS question 10
- Significant other psychiatric illness which would interfere with trial assessments - co-morbid generalised anxiety disorder (GAD) and panic disorder will be permitted where MDD is considered the primary diagnosis
- Significant physical illness which would interfere with trial assessments
- Reduced hepatic function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citalopram + PipamperoneCitalopram, 40 mg daily, 8 weeks Pipamperone, 5 mg twice daily, 8 weeks | Drug | 1 |
| CitalopramCitalopram, 40 mg daily, 8 weeks Placebo, dummy, twice a day, 8 weeks | Drug | 2 |
Primary outcome
Change in Montgomery-Asberg Depression Rating Scale score
Time frame: 8 weeks
1 secondary outcome
The number of patients showing evidence of onset of action defined as a 20% improvement from baseline MADRS
Time frame: At Weeks 1 and 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
- Results publication: PubMed 21349239Wade AG, Crawford GM, Nemeroff CB, Schatzberg AF, Schlaepfer T, McConnachie A, Haazen L, Buntinx E. Citalopram plus low-dose pipamperone versus citalopram plus placebo in patients with major depressive disorder: an 8-week, double-blind, randomized study on magnitude and timing of clinical response. Psychol Med. 2011 Oct;41(10):2089-97. doi: 10.1017/S0033291711000158. Epub 2011 Feb 25.
- Pubmed abstractLink provided by the sponsor.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Buntinx, MD study chair
PharmaNeuroBoost N.V.
Alan Wade, MG study director
CPSResearch
Gordon Crawford, MD principal investigator
CPSResearch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Citalopram + Pipamperone and Citalopram in people with Depression, run by PharmaNeuroBoost N.V. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery-Asberg Depression Rating Scale score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00672659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2011.