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Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression

NCT ID: NCT00159146

Last Updated: 2007-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2007-09-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Major Depression

Keywords

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Major Depression Pindolol Venlafaxine Augmentation Major depression (DSM-IVR)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Venlafaxine and pindolol

Group Type ACTIVE_COMPARATOR

Pindolol and venlafaxin

Intervention Type DRUG

pindolol 20 mg and venlafaxin 150 mg

B

Venlafaxin and placebo

Group Type PLACEBO_COMPARATOR

Pindolol and venlafaxin

Intervention Type DRUG

pindolol 20 mg and venlafaxin 150 mg

Interventions

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Pindolol and venlafaxin

pindolol 20 mg and venlafaxin 150 mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role collaborator

Tvergaards Foundation

UNKNOWN

Sponsor Role collaborator

Hillerod Hospital, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Psychiatric Research Unit, Hillerod Hospital

Principal Investigators

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Per Bech, Professor

Role: STUDY_CHAIR

Psychiatric Research Unit, Hillerod Hospital

Locations

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Psychiatric Research Unit, Hillerod Hospital

Hillerød, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 22458638 (View on PubMed)

Other Identifiers

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version 5

Identifier Type: -

Identifier Source: org_study_id