Trial of Pindolol Augmentation in Venlafaxine Treated Pat... | NCT00159146

Studies
Trial of Pindolol Augmentation in Venlafaxine Treated Patients With Major Depression

NCT00159146

Sponsor

Hillerod Hospital, Denmark

Status

Terminated

Last Update Posted

Dec 27, 2007Estimated

Enrollment

31Actual

Phase

Not Applicable

Conditions

Major Depression

Interventions

Pindolol and venlafaxin

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of participants fulfilling inclusion criteria

Expanded Access Info

Start Date

Aug 2002

Primary Completion Date

Not provided

Completion Date

Sep 2007Actual

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2007

Last Update Posted Date

Dec 27, 2007Estimated

Name	Class
Wyeth is now a wholly owned subsidiary of Pfizer	INDUSTRY
Tvergaards Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	Venlafaxine and pindolol	Drug: Pindolol and venlafaxin
B	Placebo Comparator	Venlafaxin and placebo	Drug: Pindolol and venlafaxin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pindolol and venlafaxin	Drug	pindolol 20 mg and venlafaxin 150 mg	A B

Measure	Description	Time Frame
Hamilton Depression Rating Scale scores		1 week

Measure	Description	Time Frame
Preskorn scores		one day

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Per Bech, Professor	Psychiatric Research Unit, Hillerod Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Psychiatric Research Unit, Hillerod Hospital		Hillerød		3400	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22458638	Derived	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.

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols