Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder

NCT00266409 | Completed Phase 4 Results

• 1 other identifier: SP0851
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

Brief Summary

An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed Selective Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) to that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at least 18 years of age and positive for Generalized Anxiety Disorder (GAD)or Panic Disorder. Subjects will be randomized to receive concomitant Niravam™ and an SSRI/SNRI or an SSRI/SNRI alone during the study. Most symptom evaluations will be done using an automated phone interview system. There are 4 clinic visits.

Conditions

Generalized Anxiety Disorder; Panic Disorder

Outcome Measures

Primary Outcomes (2)

• Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)

  The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.

  10 weeks

• Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)

  The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.

  10 weeks

Secondary Outcomes (67)

• Change From Baseline in the Total HAM-A Score After 1 Week

  Baseline and 1 week

• Change From Baseline in the Total HAM-A Score After 2 Weeks

  Baseline and 2 Weeks

• Change From Baseline in the Total HAM-A Score After 3 Weeks

  Baseline and 3 weeks

• Change From Baseline in the Total HAM-A Score After 4 Weeks

  Baseline and 4 weeks

• Change From Baseline in the Total HAM-A Score After 5 Weeks

  Baseline and 5 weeks

Study Arms (4)

Panic: Niravam+SSRI/SNRI

EXPERIMENTAL

Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI

Drug: Niravam; Drug: SSRI/SNRI

Panic: SSRI/SNRI alone

EXPERIMENTAL

Panic Disorder: Newly prescribed SSRI or SNRI alone

Drug: SSRI/SNRI

GAD: Niravam+SSRI/SNRI

EXPERIMENTAL

Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI

Drug: Niravam; Drug: SSRI/SNRI

GAD: SSRI/SNRI alone

EXPERIMENTAL

Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Drug: SSRI/SNRI

Interventions

Niravam DRUG

Also known as: Alprazolam

GAD: Niravam+SSRI/SNRI; Panic: Niravam+SSRI/SNRI

SSRI/SNRI DRUG

Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor

GAD: Niravam+SSRI/SNRI; GAD: SSRI/SNRI alone; Panic: Niravam+SSRI/SNRI; Panic: SSRI/SNRI alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years of age.
• Diagnosed by the Investigator with primary Generalized Anxiety Disorder (GAD) and/or primary Panic Disorder with or without agoraphobia, either primary episode or recurrence, and is positive for GAD or Panic Disorder by the MHS (Mental Health Screener)).
• Receiving a new prescription for all SSRI or SNRI as indicated for GAD or Panic Disorder with or without agoraphobia. Definition of a new prescription in case of a recurrence in symptoms is no prescription or refill of prescription of SSRI or SNRI for the past 6 months.
• Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent.

You may not qualify if:

• Presence of medical condition or presence of schizophrenia, bipolar disorder, alcohol abuse/dependence or any other primary major psychiatric disorder that, in the opinion of the Investigator, would jeopardize the subject or compromise the subject's ability to participate in the trial.
• Is a current suicide risk in the opinion of the Investigator.
• Has initiated cognitive therapy within two months of Study Day 1.
• Does not speak English or does not hear well enough to be able to perform the Hamilton Anxiety (HAM-A) Rating Scale and Mental Health Screener (MHS) by Interactive Voice Response System (IVRS).
• Has taken a benzodiazepine within the past 30 days.
• History of hypersensitivity or allergic response to any of the components of SSRIs, SNRIs, benzodiazepines, or related drugs.
• If a female of child-bearing potential, is pregnant, nursing, or not using appropriate birth control methods.
• Presence of contraindications to the SSRI or SNRI to be prescribed per the specific package insert.
• Presence of acute narrow angle glaucoma or taking ketoconazole or itraconazole,which are contraindications to Niravam per the package insert.
• History of phenylketonuria (PKU).
• Participation in a previous clinical trial within 30 days prior to Study Day 1.

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (1)

Schwarz

Milwaukee, Wisconsin, United States

Location

Related Publications (2)

• Katzelnick DJ, Saidi J, Vanelli MR, Jefferson JW, Harper JM, McCrary KE. Time to response in panic disorder in a naturalistic setting: combination therapy with alprazolam orally disintegrating tablets and serotonin reuptake inhibitors compared to serotonin reuptake inhibitors alone. Psychiatry (Edgmont). 2006 Dec;3(12):39-49.

  PMID: 20877555 RESULT

• Rapaport MH, Skarky SB, Katzelnick DJ, Dewester JN, Harper JM, McCrary KE. Time to response in generalized anxiety disorder in a naturalistic setting: combination therapy with alprazolam orally disintegrating tablets and serotonin reuptake inhibitors compared to serotonin reuptake inhibitors alone. Psychiatry (Edgmont). 2006 Dec;3(12):50-9.

  PMID: 20877556 RESULT

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Generalized Anxiety Disorder; Panic Disorder

Interventions

Alprazolam

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Originally it was planned to enrol and randomize 848 subjects. The smaller than planned sample size was a result of an unusually high rate of screening failure (results published in Psychiatry 2006, Vol. 3, Issue 12 , pages 39 - 59).

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB Pharma

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2005
• First Posted: December 16, 2005
• Study Start: October 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: October 27, 2014
• Results First Posted: October 2, 2009

Record last verified: 2009-12

Locations

US (1)