NCT00159146

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

December 27, 2007

Status Verified

December 1, 2007

First QC Date

September 7, 2005

Last Update Submit

December 20, 2007

Conditions

Major Depression

Keywords

Major DepressionPindololVenlafaxineAugmentationMajor depression (DSM-IVR)

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale scores

    1 week

Secondary Outcomes (1)

  • Preskorn scores

    one day

Study Arms (2)

A

ACTIVE COMPARATOR

Venlafaxine and pindolol

Drug: Pindolol and venlafaxin

B

PLACEBO COMPARATOR

Venlafaxin and placebo

Drug: Pindolol and venlafaxin

Interventions

Pindolol and venlafaxinDRUG

pindolol 20 mg and venlafaxin 150 mg

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major depression

You may not qualify if:

  • Allergy towards pindolol, venlafaxine or other tablet constituents
  • Liver or kidney impairment
  • Diabetics
  • Age below 18 years
  • Severe cardiac disease
  • Asthma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Research Unit, Hillerod Hospital

Hillerød, 3400, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 22458638DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Pindolol

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Per Bech, Professor

    Psychiatric Research Unit, Hillerod Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

August 1, 2002

Study Completion

September 1, 2007

Last Updated

December 27, 2007

Record last verified: 2007-12

Locations

DK(1)