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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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

Primary Measures

• Hamilton Depression Rating Scale scores
  • Time Frame: 1 week
    Safety Issue?: No

Secondary Measures

• Preskorn scores
  • Time Frame: one day
    Safety Issue?: No

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

Lead Sponsor: Hillerod Hospital, Denmark

Overall Clinical Trial Officials and Contacts

Per Bech, Professor Study Chair Psychiatric Research Unit, Hillerod Hospital  

Information obtained from ClinicalTrials.gov on October 06, 2008

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