Anxiety DisordersPhase 4NCT00183274

Effectiveness of Long-Term Versus Short-Term Treatment of Generalized Anxiety Disorder With Venlafaxine XR

A Phase 4 study testing Venlafaxine XR in people with Anxiety Disorders, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anxiety Disorders
What is being tested?: Venlafaxine XR
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 268 participants
Where: 1 siteUnited States
Study dates: Jan 2004to Sep 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania, 3535 Market Street, Suite 670
Philadelphia, Pennsylvania, 19104-3309

Other trials in United States

About this study

Official title: Short-term Versus Long-term Treatment in Generalized Anxiety Disorder

Read the detailed description

Generalized anxiety disorder (GAD) is a highly prevalent, chronic psychiatric disorder. Despite the fact that GAD frequently demands prolonged treatment with medication, very little is known about the benefits of long-term treatment. GAD is characterized by 6 months or more of exaggerated worry and tension that is unfounded or much more severe than the normal anxiety most people experience. People with GAD are unable to relax and often suffer from insomnia. Venlafaxine XR, a drug used to treat depression, has been shown to be effective in the short-term treatment of GAD. However, its benefits over a course of more than 8 weeks have not been assessed. This study will evaluate the effectiveness of venlafaxine XR in treating GAD on a long-term basis and preventing the relapse of GAD after 6 months of treatment versus 12 months of treatment.

Participants in this double-blind study will first receive 6 months of open-label treatment with venlafaxine XR. Upon completion of this initial phase, participants will be randomly assigned to either continue on venlafaxine XR or begin taking placebo. After 12 months, participants taking venlafaxine XR will be randomly assigned to continue on the drug or switch to placebo. Participants will have 22 study visits over at least 18 months. Follow-up visits will occur 24 months after enrollment. Relapse of GAD will be assessed with the Hamilton Anxiety Scale and Global Severity and Improvement Scale. A variety of methods, including questionnaires and standardized scales, will be used to assess secondary outcomes.

Conditions: Anxiety Disorders
Being tested: Venlafaxine XR, Placebo
Keywords: Generalized Anxiety Disorder, Chronic Mediation Treatment, Double-Blind, Placebo Controlled, Venlafaxine XR, Relapse
Medical subject headings: Anxiety Disorders, Generalized Anxiety Disorder, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Venlafaxine XRDrug
Also called selective serotonin and norepinephrine reuptake inhibitors, Effexor, Effexor XR, Venlafaxine hydrochloride extended release
Six month intervention of Venlafaxine XR treatment with flexible range of 75 to 225 mg/d
PlaceboDrug
six month intervention with placebo drug

Study groups in NCT00183274
Study group	Role	What they receive
Open-Label Group	Active comparator	6-month randomized phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

Clinical Global Impressions, Severity of Illness
The CGI provides an overall clinician-determined summary measure that takes into account a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.
The CGI is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Results of the "Placebo After Placebo" group in Phase 3 were not entered due to sample size limitations.
Measured: Measured at Months 6 (Open Label), 12 (Double-Blind), 18 (Double-Blind, and 24 (Double-Blind Relapse)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2004Sep 2009

First posted16 Sep 2005 (estimated)
Study startJan 2004
Primary completionSep 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Anxiety DisordersStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 268 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00183274
Sponsor's protocol ID: MH65963
Other IDs: R01MH065963
Status last verified: Nov 2016
First submitted: 12 Sep 2005
Last updated: 16 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 24061331
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.
PubMed 21135327
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.
PubMed 28437668
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.
PubMed 24723432
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.
PubMed 23972788
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.
PubMed 23658070
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.
PubMed 22907732
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.
PubMed 22417933
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.
PubMed 22006095
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.
PubMed 21889574

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short-term Versus Long-term Treatment in Generalized Anxiety Disorder
ClinicalTrials.gov ID: NCT00183274
Acronym / sponsor ID: MH65963
Conditions: Anxiety Disorders
Keywords: Generalized Anxiety Disorder, Chronic Mediation Treatment, Double-Blind, Placebo Controlled, Venlafaxine XR, Relapse
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 268 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Jan 2004
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 16 Sep 2005 (estimated)
Results: Posted 30 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Open-Label Group	Active comparator	Drug: Venlafaxine XR6-month randomized phase of Venlafaxine XR at a flexible dose of 75 - 225 mg/d
Double-Blind Drug Group	Active comparator	Drug: Venlafaxine XR6-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
Double-Blind Placebo Group	Placebo comparator	Drug: Placebo6-month randomized, double blind phase of placebo occurring between months 6 - 12 of the study
Double-Blind Drug-After-Drug Group	Active comparator	Drug: Venlafaxine XR6-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
Double-Blind Placebo-After-Drug Group	Placebo comparator	Drug: Placebo6-month randomized, double blind phase of placebo occurring between months 13 - 19 of the study
Double-Blind Placebo-After-Placebo Group	Placebo comparator	Drug: Placebo6-month randomized, double blind phase of placebo occurring between months 13 - 19 of the study

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Venlafaxine XRAlso: selective serotonin and norepinephrine reuptake inhibitors, Effexor, Effexor XR, Venlafaxine hydrochloride extended releaseSix month intervention of Venlafaxine XR treatment with flexible range of 75 to 225 mg/d	Drug	Double-Blind Drug Group, Double-Blind Drug-After-Drug Group, Open-Label Group
Placebosix month intervention with placebo drug	Drug	Double-Blind Placebo Group, Double-Blind Placebo-After-Drug Group, Double-Blind Placebo-After-Placebo Group

Primary outcome

Hamilton Rating Scale for Anxiety
Time frame: Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse)
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.

1 secondary outcome

Clinical Global Impressions, Severity of Illness
Time frame: Measured at Months 6 (Open Label), 12 (Double-Blind), 18 (Double-Blind, and 24 (Double-Blind Relapse)

Results and safety

Results posted to the registry on 30 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: Open-Label	268	158
Phase 2: Double-Blind Venlafaxine XR	0	0
Phase 2: Double-Blind Placebo	0	0
Phase 3: Double-Blind Relapse Phase (Drug After Drug)	0	0
Phase 3: Double-Blind Relapse Phase (Placebo After Drug)	0	0
Phase 3: Double-Blind Relapse Phase (Placebo After Placebo)	0	0

Primary outcome: Hamilton Rating Scale for Anxiety

Time frame: Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse). Mean (Standard Deviation). Unit: HAM-A Rating Score

Measure	Open-Label: Venlafaxine XR n = 268	Double-Blind Venlafaxine XR n = 82	Double-Blind Placebo n = 54	Double-Blind Relapse Drug After Drug n = 15	Double-Blind Relapse Placebo After Drug n = 34	Double-Blind Placebo After Placebo n = 10
Value	4.17 (3.10)	6.29 (5.44)	11.35 (5.51)	5.80 (4.95)	8.42 (6.12)	6.19 (5.76)

Population analysed: The primary efficacy analytic method was time-to-relapse analyses estimated using a discrete-time Cox proportional hazards model.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Venlafaxine XR	0 of 268 (0%)	219 of 268 (81.7%)	Not reported

Limitations and caveats (from the sponsor): Increased attrition occurring as a function of trial length

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24061331Rickels 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.
Results publication: PubMed 21135327Rickels 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.
Derived from this study: PubMed 28437668Jung 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.
Derived from this study: PubMed 24723432Saung 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.
Derived from this study: PubMed 23972788Cooper 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.
Derived from this study: PubMed 23658070Cooper 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.
Derived from this study: PubMed 22907732Lohoff 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.
Derived from this study: PubMed 22417933Narasimhan 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.
Derived from this study: PubMed 22006095Lohoff 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.
Derived from this study: PubMed 21889574Narasimhan 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karl Rickels, MD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Venlafaxine XR in people with Anxiety Disorders, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Rating Scale for Anxiety (time frame: Measured at Months 6 (Open Label), 12 (Double-Blind), and 18 (Double-Blind Relapse)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00183274, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.