Phase 4
N=418
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
Generalized Anxiety Disorder · Panic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00266409 ↗Enrolled (actual)
418
Serious AEs
1.7%
Results posted
Oct 2009
Primary outcome: Primary: 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) — 1.60; 0.83; 1.49; 1.61 cumulative percent of responders — p=0.1143
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Niravam (Drug); SSRI/SNRI (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Jun 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
1.60; 0.83; 1.49; 1.61; 3.20; 21.73 | 0.1143 |
| PRIMARY 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) |
1.92; 0.94; 1.89; 2.04; 35.58; 24.53 | 0.044 sig |
| SECONDARY Change From Baseline in the Total HAM-A Score After 1 Week |
-9.3; -5.8; -7.8; -4.6 | 0.0173 sig |
| SECONDARY Change From Baseline in the Total HAM-A Score After 2 Weeks |
-11.6; -8.2; -10.0; -6.1 | 0.0361 sig |
| SECONDARY Change From Baseline in the Total HAM-A Score After 3 Weeks |
-14.3; -12.9; -10.9; -9.5 | 0.7390 |
| SECONDARY Change From Baseline in the Total HAM-A Score After 4 Weeks |
-15.2; -13.7; -12.9; -8.3 | 0.4261 |
| SECONDARY Change From Baseline in the Total HAM-A Score After 5 Weeks |
-16.7; -14.4; -13.3; -10.3 | 0.1820 |
| SECONDARY Change From Baseline in the Total HAM-A Score After 6 Weeks |
-17.7; -15.1; -13.4; -11.0 | 0.1456 |
| SECONDARY Change From Baseline in the Total HAM-A Score After 7 Weeks |
-17.7; -15.6; -13.3; -11.3 | 0.3535 |
| SECONDARY Change From Baseline in the Total HAM-A Score After 8 Weeks |
-18.5; -16.6; -13.9; -12.3 | 0.3414 |
| SECONDARY Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period |
-17.3; -14.3; -13.6; -11.5 | 0.1197 |
| SECONDARY Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week |
39; 24; 22; 16; 73; 85 | 0.0350 sig |
| SECONDARY Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks |
48; 38; 30; 23; 60; 65 | 0.2645 |
| SECONDARY Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks |
56; 51; 33; 31; 45; 41 | 0.9988 |
| SECONDARY Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks |
58; 56; 37; 25; 39; 34 | 0.7338 |
| SECONDARY Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks |
59; 51; 33; 30; 30; 30 | 0.6501 |
| SECONDARY Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks |
63; 56; 31; 32; 24; 25 | 0.6404 |
| SECONDARY Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks |
60; 57; 37; 34; 23; 25 | 0.6946 |
| SECONDARY Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks |
61; 62; 38; 35; 23; 22 | 0.8617 |
| SECONDARY Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period |
78; 74; 44; 40; 39; 43 | 0.5836 |
| SECONDARY Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks |
6; 1; 4; 2; 38; 23 | 0.0002 sig |
| SECONDARY Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks |
18; 5; 12; 1; 40; 40 | 0.0255 sig |
| SECONDARY Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks |
28; 27; 14; 12; 44; 27 | 0.0370 sig |
| SECONDARY Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period |
31; 27; 14; 12; 47; 31 | 0.0978 |
| SECONDARY Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week |
7; 0; 3; 0; 24; 5 | 0.0001 sig |
| SECONDARY Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks |
10; 2; 5; 4; 30; 16 | 0.0025 sig |
| SECONDARY Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks |
22; 7; 10; 2; 23; 21 | 0.0095 sig |
| SECONDARY Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks |
18; 13; 13; 6; 38; 24 | 0.0160 sig |
| SECONDARY Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks |
21; 10; 13; 5; 32; 27 | 0.0761 |
| SECONDARY Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks |
22; 16; 15; 6; 29; 24 | 0.1196 |
| SECONDARY Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks |
23; 21; 12; 8; 28; 24 | 0.6323 |
| SECONDARY Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks |
28; 23; 20; 13; 28; 22 | 0.1705 |
| SECONDARY Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period |
34; 25; 21; 14; 36; 27 | 0.0419 sig |
| SECONDARY Change From Baseline in HAM-A-insomnia Subscore After 1 Week |
-0.9; -0.6; -1.0; -0.5 | 0.0677 |
| SECONDARY Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks |
-1.0; -0.9; -1.2; -0.6 | 0.5153 |
| SECONDARY Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks |
-1.2; -1.1; -1.4; -1.2 | 0.4648 |
| SECONDARY Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks |
-1.3; -1.4; -1.6; -1.1 | 0.9093 |
| SECONDARY Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks |
-1.3; -1.4; -1.5; -1.1 | 0.7434 |
| SECONDARY Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks |
-1.4; -1.5; -1.6; -1.1 | 0.9346 |
| SECONDARY Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks |
-1.5; -1.4; -1.6; -1.2 | 0.3827 |
| SECONDARY Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks |
-1.6; -1.6; -1.6; -1.3 | 0.3930 |
| SECONDARY Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period |
-1.6; -1.4; -1.5; -1.3 | 0.0722 |
| SECONDARY Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week |
-4.9; -2.9; -4.5; -3.3 | 0.0075 sig |
| SECONDARY Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks |
-6.0; -4.5; -5.8; -4.1 | 0.0932 |
| SECONDARY Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks |
-7.3; -6.8; -6.4; -6.1 | 0.7896 |
| SECONDARY Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks |
-7.7; -7.4; -7.8; -5.9 | 0.8280 |
| SECONDARY Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks |
-8.7; -7.7; -7.9; -6.8 | 0.3539 |
| SECONDARY Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks |
-9.4; -8.3; -8.7; -7.2 | 0.2550 |
| SECONDARY Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks |
-9.6; -8.4; -8.1; -7.6 | 0.3174 |
| SECONDARY Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks |
-9.9; -8.9; -8.5; -8.5 | 0.3252 |
| SECONDARY Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period |
-9.1; -7.6; -7.9; -7.9 | 0.1247 |
| SECONDARY Change From Baseline in HAM-A-somatic Subscore After 1 Week |
-4.4; -2.9; -3.3; -1.4 | 0.1031 |
| SECONDARY Change From Baseline in HAM-A-somatic Subscore After 2 Weeks |
-5.6; -3.7; -4.2; -2.0 | 0.0508 |
| SECONDARY Change From Baseline in HAM-A-somatic Subscore After 3 Weeks |
-7.0; -6.1; -4.5; -3.4 | 0.8318 |
| SECONDARY Change From Baseline in HAM-A-somatic Subscore After 4 Weeks |
-7.5; -6.4; -5.1; -2.3 | 0.2186 |
| SECONDARY Change From Baseline in HAM-A-somatic Subscore After 5 Weeks |
-8.0; -6.8; -5.4; -3.4 | 0.1164 |
| SECONDARY Change From Baseline in HAM-A-somatic Subscore After 6 Weeks |
-8.3; -6.8; -4.7; -3.8 | 0.1244 |
| SECONDARY Change From Baseline in HAM-A-somatic Subscore After 7 Weeks |
-8.1; 7.2; -5.2; -3.7 | 0.4589 |
| SECONDARY Change From Baseline in HAM-A-somatic Subscore After 8 Weeks |
-8.6; -7.7; -5.5; -3.8 | 0.4450 |
| SECONDARY Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period |
-8.2; -6.7; -5.6; -3.6 | 0.2184 |
| SECONDARY Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week |
76; 69; 42; 43 | 0.6602 |
| SECONDARY Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks |
60; 60; 54; 46 | 0.5544 |
| SECONDARY Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks |
41; 37; 66; 58 | 0.9269 |
| SECONDARY Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks |
43; 43; 60; 50 | 0.5271 |
| SECONDARY Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks |
35; 40; 60; 44 | 0.1447 |
| SECONDARY Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks |
36; 33; 57; 51 | 0.9375 |
| SECONDARY Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks |
32; 31; 56; 54 | 0.9883 |
| SECONDARY Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks |
26; 32; 62; 55 | 0.3093 |
| SECONDARY Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period |
47; 50; 76; 70 | 0.5824 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00266409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.