Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression

Major Depression Clinical Trial

Official title:

A Short Term Double Blind Randomised Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00159146
• Other study ID #: version 5
• Status: Terminated
• Phase: N/A
• First received: September 7, 2005
• Last updated: December 20, 2007
• Start date: August 2002
• Est. completion date: September 2007

Study information

• Verified date: December 2007
• Source: Hillerod Hospital, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This study investigates the hypothesis that pindolol can accelerate the response to antidepressants in patients with major depression treated with venlafaxine.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• Pindolol and venlafaxin
pindolol 20 mg and venlafaxin 150 mg

Locations

Country	Name	City	State
Denmark	Psychiatric Research Unit, Hillerod Hospital	Hillerod

Sponsors (3)

Lead Sponsor	Collaborator
Hillerod Hospital, Denmark	Tvergaards Foundation, Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale scores		1 week	No
Secondary	Preskorn scores		one day	No