NCT00183274

Brief Summary

This study will assess the effectiveness of venlafaxine XR, randomized to either venlafaxine XR or placebo in preventing the relapse of generalized anxiety disorder after 6 months of treatment versus 12 months of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
7.3 years until next milestone

Results Posted

Study results publicly available

November 30, 2016

Completed
Last Updated

January 16, 2017

Status Verified

November 1, 2016

Enrollment Period

5.7 years

First QC Date

September 12, 2005

Results QC Date

December 14, 2012

Last Update Submit

November 29, 2016

Conditions

Anxiety Disorders

Keywords

Generalized Anxiety DisorderChronic Mediation TreatmentDouble-BlindPlacebo ControlledVenlafaxine XRRelapse

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Anxiety

    Hamilton Rating Scale for Anxiety - The assessment of anxiety states by rating Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

    Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse)

Secondary Outcomes (1)

  • Clinical Global Impressions, Severity of Illness

    Measured at Months 6 (Open Label), 12 (Double-Blind), 18 (Double-Blind, and 24 (Double-Blind Relapse)

Study Arms (6)

Open-Label Group

ACTIVE COMPARATOR

6-month randomized phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d

Drug: Venlafaxine XR

Double-Blind Drug Group

ACTIVE COMPARATOR

6-month randomized, double-blind phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d occurring between months 6 - 12 of the study

Drug: Venlafaxine XR

Double-Blind Placebo Group

PLACEBO COMPARATOR

6-month randomized, double blind phase of placebo occurring between months 6 - 12 of the study

Drug: Placebo

Double-Blind Drug-After-Drug Group

ACTIVE COMPARATOR

6-month randomized, double blind phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d occurring between months 13 - 19 of the study

Drug: Venlafaxine XR

Double-Blind Placebo-After-Drug Group

PLACEBO COMPARATOR

6-month randomized, double blind phase of placebo occurring between months 13 - 19 of the study

Drug: Placebo

Double-Blind Placebo-After-Placebo Group

PLACEBO COMPARATOR

6-month randomized, double blind phase of placebo occurring between months 13 - 19 of the study

Drug: Placebo

Interventions

Venlafaxine XRDRUG

Six month intervention of Venlafaxine XR treatment with flexible range of 75 to 225 mg/d

Also known as: selective serotonin and norepinephrine reuptake inhibitors, Effexor, Effexor XR, Venlafaxine hydrochloride extended release, Trevilor, Lanvexin
Double-Blind Drug GroupDouble-Blind Drug-After-Drug GroupOpen-Label Group
PlaceboDRUG

six month intervention with placebo drug

Double-Blind Placebo GroupDouble-Blind Placebo-After-Drug GroupDouble-Blind Placebo-After-Placebo Group

Eligibility Criteria

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

You may qualify if:

  • GAD diagnosis by structured interview
  • Hamilton Anxiety Scale score of 18 or MORE
  • Clinical Global Impressions Severity Scale score of at least 4
  • Hamilton Depression Scale score of 18 or less
  • Hamilton Depression Scale suicide item score less than 2
  • Use of an effective form of contraception throughout the study

You may not qualify if:

  • Hypersensitivity to venlafaxine XR
  • History of seizures
  • Episode of major depressive disorder in the previous 6 months
  • History of any psychotic illness, bipolar disorder, or dementia
  • Substance abuse and dependence during the past 6 months
  • Other anxiety disorders with the exception of social phobia as long as GAD is primary
  • Regular use of anxiolytics or antidepressants within 7 days of study onset
  • Use of fluoxetine or monoamine oxidase inhibitors within 28 days of study onset (low dose usage of benzodiazepines will not prevent participation)
  • Use of other psychotropic medication besides benzodiazepines during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania, 3535 Market Street, Suite 670

Philadelphia, Pennsylvania, 19104-3309, United States

Location

Related Publications (10)

  • Rickels K, Etemad B, Rynn MA, Lohoff FW, Mandos LA, Gallop R. Remission of generalized anxiety disorder after 6 months of open-label treatment with venlafaxine XR. Psychother Psychosom. 2013;82(6):363-71. doi: 10.1159/000351410. Epub 2013 Sep 20.

    PMID: 24061331BACKGROUND

  • Rickels K, Etemad B, Khalid-Khan S, Lohoff FW, Rynn MA, Gallop RJ. Time to relapse after 6 and 12 months' treatment of generalized anxiety disorder with venlafaxine extended release. Arch Gen Psychiatry. 2010 Dec;67(12):1274-81. doi: 10.1001/archgenpsychiatry.2010.170.

    PMID: 21135327RESULT

  • Jung J, Tawa EA, Muench C, Rosen AD, Rickels K, Lohoff FW. Genome-wide association study of treatment response to venlafaxine XR in generalized anxiety disorder. Psychiatry Res. 2017 Aug;254:8-11. doi: 10.1016/j.psychres.2017.04.025. Epub 2017 Apr 14.

    PMID: 28437668DERIVED

  • Saung WT, Narasimhan S, Lohoff FW. Lack of influence of DAT1 and DRD2 gene variants on antidepressant response in generalized anxiety disorder. Hum Psychopharmacol. 2014 Jul;29(4):316-21. doi: 10.1002/hup.2404. Epub 2014 Apr 10.

    PMID: 24723432DERIVED

  • Cooper AJ, Narasimhan S, Rickels K, Lohoff FW. Genetic polymorphisms in the PACAP and PAC1 receptor genes and treatment response to venlafaxine XR in generalized anxiety disorder. Psychiatry Res. 2013 Dec 30;210(3):1299-300. doi: 10.1016/j.psychres.2013.07.038. Epub 2013 Aug 22.

    PMID: 23972788DERIVED

  • Cooper AJ, Rickels K, Lohoff FW. Association analysis between the A118G polymorphism in the OPRM1 gene and treatment response to venlafaxine XR in generalized anxiety disorder. Hum Psychopharmacol. 2013 May;28(3):258-62. doi: 10.1002/hup.2317. Epub 2013 May 8.

    PMID: 23658070DERIVED

  • Lohoff FW, Narasimhan S, Rickels K. Interaction between polymorphisms in serotonin transporter (SLC6A4) and serotonin receptor 2A (HTR2A) genes predict treatment response to venlafaxine XR in generalized anxiety disorder. Pharmacogenomics J. 2013 Oct;13(5):464-9. doi: 10.1038/tpj.2012.33. Epub 2012 Aug 21.

    PMID: 22907732DERIVED

  • Narasimhan S, Aquino TD, Multani PK, Rickels K, Lohoff FW. Variation in the catechol-O-methyltransferase (COMT) gene and treatment response to venlafaxine XR in generalized anxiety disorder. Psychiatry Res. 2012 Jun 30;198(1):112-5. doi: 10.1016/j.psychres.2011.12.034. Epub 2012 Mar 13.

    PMID: 22417933DERIVED

  • Lohoff FW, Aquino TD, Narasimhan S, Multani PK, Etemad B, Rickels K. Serotonin receptor 2A (HTR2A) gene polymorphism predicts treatment response to venlafaxine XR in generalized anxiety disorder. Pharmacogenomics J. 2013 Feb;13(1):21-6. doi: 10.1038/tpj.2011.47. Epub 2011 Oct 18.

    PMID: 22006095DERIVED

  • Narasimhan S, Aquino TD, Hodge R, Rickels K, Lohoff FW. Association analysis between the Val66Met polymorphism in the brain-derived neurotrophic factor (BDNF) gene and treatment response to venlafaxine XR in generalized anxiety disorder. Neurosci Lett. 2011 Oct 10;503(3):200-2. doi: 10.1016/j.neulet.2011.08.035. Epub 2011 Aug 26.

    PMID: 21889574DERIVED

MeSH Terms

Conditions

Anxiety DisordersGeneralized Anxiety DisorderRecurrence

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Mental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Limitations and Caveats

Increased attrition occurring as a function of trial length

Results Point of Contact

Title
Karl Rickels, M.D.
Organization
UPENN
krickels@mail.med.upenn.edu
215-746-6417

Study Officials

  • Karl Rickels, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

January 1, 2004

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 16, 2017

Results First Posted

November 30, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)