We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression

This study has been terminated.
(lack of participants fulfilling inclusion criteria)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00159146
First Posted: September 12, 2005
Last Update Posted: December 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
Tvergaards Foundation
Information provided by:
Hillerod Hospital, Denmark
  Purpose
This study investigates the hypothesis that pindolol can accelerate the response to antidepressants in patients with major depression treated with venlafaxine.

Condition Intervention
Major Depression Drug: Pindolol and venlafaxin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Short Term Double Blind Randomised Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression

Resource links provided by NLM:


Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale scores [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • Preskorn scores [ Time Frame: one day ]

Enrollment: 31
Study Start Date: August 2002
Study Completion Date: September 2007
Arms Assigned Interventions
Active Comparator: A
Venlafaxine and pindolol
Drug: Pindolol and venlafaxin
pindolol 20 mg and venlafaxin 150 mg
Placebo Comparator: B
Venlafaxin and placebo
Drug: Pindolol and venlafaxin
pindolol 20 mg and venlafaxin 150 mg

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159146


Locations
Denmark
Psychiatric Research Unit, Hillerod Hospital
Hillerod, Denmark, 3400
Sponsors and Collaborators
Hillerod Hospital, Denmark
Wyeth is now a wholly owned subsidiary of Pfizer
Tvergaards Foundation
Investigators
Study Chair: Per Bech, Professor Psychiatric Research Unit, Hillerod Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Klaus Martiny, Psychiatric Research Unit, Hillerod Hospital
ClinicalTrials.gov Identifier: NCT00159146     History of Changes
Other Study ID Numbers: version 5
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: December 27, 2007
Last Verified: December 2007

Keywords provided by Hillerod Hospital, Denmark:
Major Depression
Pindolol
Venlafaxine
Augmentation
Major depression (DSM-IVR)

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Venlafaxine Hydrochloride
Pindolol
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Antihypertensive Agents
Serotonin Antagonists
Serotonin Agents
Vasodilator Agents