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Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression

Primary Purpose

Major Depression

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pindolol and venlafaxin
Sponsored by
Hillerod Hospital, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Major Depression, Pindolol, Venlafaxine, Augmentation, Major depression (DSM-IVR)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Psychiatric Research Unit, Hillerod Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Venlafaxine and pindolol

Venlafaxin and placebo

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale scores

Secondary Outcome Measures

Preskorn scores

Full Information

First Posted
September 7, 2005
Last Updated
December 20, 2007
Sponsor
Hillerod Hospital, Denmark
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer, Tvergaards Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00159146
Brief Title
Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression
Official Title
A Short Term Double Blind Randomised Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Why Stopped
lack of participants fulfilling inclusion criteria
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hillerod Hospital, Denmark
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer, Tvergaards Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Major Depression, Pindolol, Venlafaxine, Augmentation, Major depression (DSM-IVR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Venlafaxine and pindolol
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Venlafaxin and placebo
Intervention Type
Drug
Intervention Name(s)
Pindolol and venlafaxin
Intervention Description
pindolol 20 mg and venlafaxin 150 mg
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale scores
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Preskorn scores
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Bech, Professor
Organizational Affiliation
Psychiatric Research Unit, Hillerod Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Psychiatric Research Unit, Hillerod Hospital
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
22458638
Citation
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.
Results Reference
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Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression

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