Major DepressionNCT00159146
Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression
A study testing Pindolol and venlafaxin in people with Major Depression, run by Hillerod Hospital, Denmark at 1 site in Denmark.
Trial summary
This study investigates the hypothesis that pindolol can accelerate the response to antidepressants in patients with major depression treated with venlafaxine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depression
- What is being tested?
- Pindolol and venlafaxin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2002to Sep 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depression
Who cannot join
- Allergy towards pindolol, venlafaxine or other tablet constituents
- Liver or kidney impairment
- Diabetics
- Age below 18 years
- Severe cardiac disease
- Asthma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Short Term Double Blind Randomised Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression
This study investigates the hypothesis that pindolol can accelerate the response to antidepressants in patients with major depression treated with venlafaxine.
Read the detailed description
Antidepressant therapy has a delayed onset of action of 4-6 weeks. Pindolol has in some studies shown an accelerating effect. In this study we investigate the effect of 20 mg of pindolol retarded formulation in combination with Venlafaxine compared to placebo Pindolol and Venlafaxine for a duration of 19 days.
Effect is measured by the Hamilton Depression rating Scale and the Preskorn Scale (self-rating).
- Conditions
- Major Depression
- Being tested
- Pindolol and venlafaxin
- Keywords
- Major Depression, Pindolol, Venlafaxine, Augmentation, Major depression (DSM-IVR)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pindolol and venlafaxinDrug
pindolol 20 mg and venlafaxin 150 mg
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Venlafaxine and pindolol Receives: Drug: Pindolol and venlafaxin |
| B | Placebo comparator | Venlafaxin and placebo Receives: Drug: Pindolol and venlafaxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale scores
Measured: 1 week
Secondary outcomes (1)
Preskorn scores
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2002
- Study completionSep 2007
Why it stopped: lack of participants fulfilling inclusion criteria
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 Major 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillerod Hospital, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer, Tvergaards Foundation
- Investigators
- Per Bech, Professor, Study chair, Psychiatric Research Unit, Hillerod Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159146
- Sponsor's protocol ID
- version 5
- Status last verified
- Dec 2007
- First submitted
- 7 Sep 2005
- Last updated
- 27 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Martiny K, Lunde M, Bech P, Plenge P. A short-term double-blind randomized controlled pilot trial with active or placebo pindolol in patients treated with venlafaxine for major depression. Nord J Psychiatry. 2012 Jun;66(3):147-54. doi: 10.3109/08039488.2012.674553. Epub 2012 Mar 29.
PubMed 22458638
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Short Term Double Blind Randomised Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression
- ClinicalTrials.gov ID
- NCT00159146
- Acronym / sponsor ID
- version 5
- Conditions
- Major Depression
- Keywords
- Major Depression, Pindolol, Venlafaxine, Augmentation, Major depression (DSM-IVR)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of participants fulfilling inclusion criteria
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer, Tvergaards Foundation
- Study start
- Aug 2002
- Study completion
- Sep 2007 (actual)
- First posted
- 12 Sep 2005 (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.
This study investigates the hypothesis that pindolol can accelerate the response to antidepressants in patients with major depression treated with venlafaxine.
Detailed description
Antidepressant therapy has a delayed onset of action of 4-6 weeks. Pindolol has in some studies shown an accelerating effect. In this study we investigate the effect of 20 mg of pindolol retarded formulation in combination with Venlafaxine compared to placebo Pindolol and Venlafaxine for a duration of 19 days.
Effect is measured by the Hamilton Depression rating Scale and the Preskorn Scale (self-rating).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Pindolol and venlafaxinVenlafaxine and pindolol |
| B | Placebo comparator | Drug: Pindolol and venlafaxinVenlafaxin and placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major depression
Key exclusion criteria (6 listed)
- Allergy towards pindolol, venlafaxine or other tablet constituents
- Liver or kidney impairment
- Diabetics
- Age below 18 years
- Severe cardiac disease
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 |
|---|---|---|
| Pindolol and venlafaxinpindolol 20 mg and venlafaxin 150 mg | Drug | A, B |
Primary outcome
Hamilton Depression Rating Scale scores
Time frame: 1 week
1 secondary outcome
Preskorn scores
Time frame: one day
Results and safety
The study was stopped early (reason given: lack of participants fulfilling inclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2007.
- Derived from this study: PubMed 22458638Martiny K, Lunde M, Bech P, Plenge P. A short-term double-blind randomized controlled pilot trial with active or placebo pindolol in patients treated with venlafaxine for major depression. Nord J Psychiatry. 2012 Jun;66(3):147-54. doi: 10.3109/08039488.2012.674553. Epub 2012 Mar 29.
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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.
Per Bech, Professor study chair
Psychiatric Research Unit, Hillerod Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pindolol and venlafaxin in people with Major Depression, run by Hillerod Hospital, Denmark at 1 site in Denmark.
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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 Dec 2007. 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 Denmark. 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.
Are results available for this study?
The study was stopped early (reason given: lack of participants fulfilling inclusion criteria). Results are not available in the source record.
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?
Hamilton Depression Rating Scale scores (time frame: 1 week). 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 NCT00159146, 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 27 Dec 2007.