- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00159146
Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression
A Short Term Double Blind Randomised Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hillerod, Denmark, 3400
- Psychiatric Research Unit, Hillerod Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Major depression
Exclusion Criteria:
- Allergy towards pindolol, venlafaxine or other tablet constituents
- Liver or kidney impairment
- Diabetics
- Age below 18 years
- Severe cardiac disease
- Asthma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
Venlafaxine and pindolol
|
pindolol 20 mg and venlafaxin 150 mg
|
Placebo Comparator: B
Venlafaxin and placebo
|
pindolol 20 mg and venlafaxin 150 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hamilton Depression Rating Scale scores
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Preskorn scores
Time Frame: one day
|
one day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Per Bech, Professor, Psychiatric Research Unit, Hillerod Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Serotonin Agents
- Serotonin Antagonists
- Pindolol
Other Study ID Numbers
- version 5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depression
-
Stanford UniversityTerminatedMajor Depressive Disorder | Major Depressive Episode | Major Depressive Disorder, Recurrent | Major Depression Mild | Major Depression Moderate | Major Depression SevereUnited States
-
Hawler Medical UniversityCompleted
-
Centre Hospitalier Universitaire de BesanconH. Lundbeck A/SCompletedResistant Major DepressionFrance
-
First Affiliated Hospital of Zhejiang UniversityNot yet recruiting
-
University of PittsburghCompletedPostpartum Major DepressionUnited States
-
Si TianmeiUnknownMajor Depression DisorderChina
-
The Hong Kong Polytechnic UniversityNot yet recruitingHealthy | Major Depression in Remission
-
AstraZenecaCompletedNon-psychotic Unipolar Major DepressionArgentina
-
Ruijin HospitalTerminatedTreatment Resistant Major Depression DisorderChina
-
Zentrum für Integrative PsychiatrieGerman Research FoundationCompletedCognitive Performance in Major DepressionGermany
Clinical Trials on Pindolol and venlafaxin
-
Actimed Therapeutics LtdQuotient SciencesCompleted
-
Markus KOSELUniversity Hospital, Geneva; H. Lundbeck A/S; University Hospital, Basel, Switzerland and other collaboratorsTerminated
-
Mark FryeUniversity of California, Los AngelesWithdrawn
-
Gitte Moos KnudsenCompleted
-
University Hospital, Basel, SwitzerlandHeffter Research InstituteCompletedSubstance-Related Disorders | Amphetamine-Related Disorders | Mood DisorderSwitzerland
-
University of OttawaUnknown
-
Fundació Institut de Recerca de l'Hospital de la...CompletedMajor Depressive Disorder | Antidepressant Treatment ResponseSpain
-
Weill Medical College of Cornell UniversityNational Institute on Aging (NIA)CompletedHeart Failure | Heart Disease | Heart Failure, Diastolic | Heart Failure With Preserved Ejection Fraction | Cardiac FailureUnited States
-
Weill Medical College of Cornell UniversityThe New York Community TrustCompletedHeart Failure | Heart Disease | Heart Failure, Diastolic | Heart Failure With Preserved Ejection Fraction | Cardiac FailureUnited States
-
University of AarhusNovartis; Danish Heart Foundation; Danish Cardiovascular Research AcademyTerminatedHypertension | Microvascular AnginaDenmark