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

UCB Pharma418 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

418

Conditions

Generalized Anxiety Disorder Panic Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 10 weeks

Secondary Outcomes

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

Time frame: Baseline and 1 week

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

Time frame: Baseline and 2 Weeks

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

Time frame: Baseline and 3 weeks

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

Time frame: Baseline and 4 weeks

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

Time frame: Baseline and 5 weeks

Change From Baseline in the Total HAM-A Score After 6 Weeks

Time frame: Baseline and 6 weeks

Change From Baseline in the Total HAM-A Score After 7 Weeks

Time frame: Baseline and 7 weeks

Change From Baseline in the Total HAM-A Score After 8 Weeks

Time frame: Baseline and 8 weeks

Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period

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). Maximum HAM-A Score is 56. Endpoint is last observed value during the 8 week treatment period.

Time frame: Baseline and at endpoint during the 8 week treatment period

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week

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).

Time frame: 1 week

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks

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).

Time frame: 2 weeks

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks

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).

Time frame: 3 weeks

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks

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).

Time frame: 4 weeks

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks

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).

Time frame: 5 weeks

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks

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).

Time frame: 6 weeks

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks

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).

Time frame: 7 weeks

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks

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).

Time frame: 8 weeks

Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period

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). Endpoint is last observed value during the 8 week treatment period.

Time frame: at endpoint during the 8 week treatment period

Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks

The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).

Time frame: Baseline and 2 weeks

Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks

Time frame: Baseline and 4 weeks

Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks

Time frame: Baseline and 8 weeks

Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period

Time frame: Baseline and at endpoint during the 8 week treatment period

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week

The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).

Time frame: 1 week

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks

The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect.

Time frame: 2 weeks

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks

Time frame: 3 weeks

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks

Time frame: 4 weeks

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks

Time frame: 5 weeks

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks

Time frame: 6 weeks

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks

Time frame: 7 weeks

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks

Time frame: 8 weeks

Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period

Time frame: at endpoint during the 8 week treatment period

Change From Baseline in HAM-A-insomnia Subscore After 1 Week

Time frame: Baseline and 1 week

Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks

Time frame: Baseline and 2 weeks

Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks

Time frame: Baseline and 3 weeks

Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks

Time frame: Baseline and 4 weeks

Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks

Time frame: Baseline and 5 weeks

Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks

Time frame: Baseline and 6 weeks

Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks

Time frame: Baseline and 7 weeks

Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks

Time frame: Baseline and 8 weeks

Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period

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). Maximum score of the insomnia subscore is 4. Endpoint is last observed value during the 8 week treatment period.

Time frame: Baseline and at endpoint during the 8 week treatment period

Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week