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...
Brief Summary
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Detailed Clinical Trial 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).
Intervention(s) in this Clinical Trial
- Drug: Pindolol and venlafaxin
- pindolol 20 mg and venlafaxin 150 mg
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: A
- Venlafaxine and pindolol
- Placebo Comparator: B
- Venlafaxin and placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Hamilton Depression Rating Scale scores
- Time Frame: 1 week
Safety Issue?: No
- Time Frame: 1 week
Secondary Measures
- Preskorn scores
- Time Frame: one day
Safety Issue?: No
- Time Frame: one day
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Hillerod Hospital, Denmark Other
Overall Clinical Trial Officials and Contacts
Per Bech, Professor Study Chair Psychiatric Research Unit, Hillerod Hospital
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00159146
Study ID Number: version 5
ClinicalTrials.gov Identifier: NCT00159146
Health Authority: Denmark: Danish Medicines Agency
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00159146
