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Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression

This study has been terminated.
(lack of participants fulfilling inclusion criteria)
Sponsor:
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
Tvergaards Foundation
Information provided by:
Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT00159146
First received: September 7, 2005
Last updated: December 20, 2007
Last verified: December 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale scores [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Preskorn scores [ Time Frame: one day ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hillerod Hospital, Denmark

Additional 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
Study First Received: September 7, 2005
Last Updated: December 20, 2007
Health Authority: Denmark: Danish Medicines Agency

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
Pindolol
Venlafaxine
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Serotonin Antagonists
Serotonin Agents
Vasodilator Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013