Trial Outcomes & Findings for Therapies for Treatment-Resistant Panic Disorder Symptoms (NCT NCT00118417)

Last Updated: 2014-06-11

Results Overview

This measure is the change in points between baseline and endpoint scores on the Panic Disorder Severity Scale (PDSS). The PDSS is a 7-item scale with each item rated from 0 (none) to 4 (extreme), for a total score range of 0 to 28 points, and an established interrater reliability of 0.87.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

46 participants

Primary outcome timeframe

Measured at baseline and after Phase 1 (6 weeks)

Results posted on

2014-06-11

Participant Flow

Participants were recruited by advertisement and referral to research at the Center for Anxiety and Traumatic Stress Related Disorders at Massachusetts General Hospital.

46 participants enrolled, but four participants were lost prior to Phase 1, two due to alcohol abuse and two due to follow-up. Participants were not randomized until the start of Phase 2.

Participant milestones

Participant milestones
Measure	Sertraline / Increased Dose / Medication Optimization In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive an increased dosage of their SSRI; In Phase 3, this group will receive medication optimization, which includes an SSRI and clonazepam	Sertraline / + Placebo / Cognitive Behavior Therapy Augment. In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive their SSRI plus a placebo; In Phase 3, this group will receive their SSRI plus cognitive behavioral therapy (CBT)
Phase I (Weeks 0 to 6) STARTED	39	0
Phase I (Weeks 0 to 6) COMPLETED	21	0
Phase I (Weeks 0 to 6) NOT COMPLETED	18	0
Phase II (Weeks 6 to 12) STARTED	11	13
Phase II (Weeks 6 to 12) COMPLETED	9	10
Phase II (Weeks 6 to 12) NOT COMPLETED	2	3
Phase III (Weeks 12 to 24) STARTED	9	10
Phase III (Weeks 12 to 24) COMPLETED	8	9
Phase III (Weeks 12 to 24) NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sertraline / Increased Dose / Medication Optimization In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive an increased dosage of their SSRI; In Phase 3, this group will receive medication optimization, which includes an SSRI and clonazepam	Sertraline / + Placebo / Cognitive Behavior Therapy Augment. In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive their SSRI plus a placebo; In Phase 3, this group will receive their SSRI plus cognitive behavioral therapy (CBT)
Phase I (Weeks 0 to 6) Remission	8	0
Phase I (Weeks 0 to 6) Lost to Follow-up	6	0
Phase I (Weeks 0 to 6) Loss of Eligibility for Phase 2	4	0
Phase II (Weeks 6 to 12) Withdrawal by Subject	1	1
Phase II (Weeks 6 to 12) Remission	1	2

Baseline Characteristics

Therapies for Treatment-Resistant Panic Disorder Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=42 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37.7 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline and after Phase 1 (6 weeks)

Population: Analyses in each study phase were for a modified intent to treat (ITT) sample, defined as all participants who had at least one on-treatment assessment during that phase.

Outcome measures

Outcome measures
Measure	Moderate Sertraline Treatment n=39 Participants This group will receive moderate sertraline or escitalopram treatment	Sertraline Plus Placebo This group will receive sertraline or escitalopram with a placebo
Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)	4.3 Points on a scale Standard Deviation 4.3	—

PRIMARY outcome

Timeframe: Measured after Phase 1 (Week 6) and Phase 2 (Week 12)

Outcome measures

Outcome measures
Measure	Moderate Sertraline Treatment n=11 Participants This group will receive moderate sertraline or escitalopram treatment	Sertraline Plus Placebo n=13 Participants This group will receive sertraline or escitalopram with a placebo
Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)	2.36 Points on a scale Standard Deviation 3.44	2.31 Points on a scale Standard Deviation 4.29

PRIMARY outcome

Timeframe: Measured after Phase 2 (Week 12) and Phase 3 (Week 24)

Outcome measures

Outcome measures
Measure	Moderate Sertraline Treatment n=9 Participants This group will receive moderate sertraline or escitalopram treatment	Sertraline Plus Placebo n=10 Participants This group will receive sertraline or escitalopram with a placebo
Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)	3.78 Points on a scale Standard Deviation 3.80	2.9 Points on a scale Standard Deviation 3.63

Adverse Events

Phase I: Sertraline

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase I: Sertraline n=39 participants at risk In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI).	Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone n=24 participants at risk	Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam n=19 participants at risk
General disorders Patient admitted to inpatient rehabiliation center for alcohol abuse	0.00% 0/39	0.00% 0/24	10.5% 2/19 • Number of events 2
General disorders Patient admitted to the hospital after experiencing symptoms similar to panic attacks.	2.6% 1/39 • Number of events 1	0.00% 0/24	0.00% 0/19
General disorders Patient was in a motorcycle accident of unknown etiology	0.00% 0/39	0.00% 0/24	5.3% 1/19 • Number of events 1
General disorders Patient was found to have blockage of one cardiac vessel	2.6% 1/39 • Number of events 1	0.00% 0/24	0.00% 0/19

Other adverse events

Other adverse events
Measure	Phase I: Sertraline n=39 participants at risk In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI).	Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone n=24 participants at risk	Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam n=19 participants at risk
Gastrointestinal disorders Gastrointestinal distress	48.7% 19/39 • Number of events 19	29.2% 7/24 • Number of events 7	31.6% 6/19 • Number of events 6
General disorders Headache	41.0% 16/39 • Number of events 16	29.2% 7/24 • Number of events 7	31.6% 6/19 • Number of events 6
General disorders Nausea or Vomiting	38.5% 15/39 • Number of events 15	0.00% 0/24	0.00% 0/19
General disorders Jitteriness or Restlesness	30.8% 12/39 • Number of events 12	16.7% 4/24 • Number of events 4	0.00% 0/19
General disorders Insomnia	28.2% 11/39 • Number of events 11	16.7% 4/24 • Number of events 4	0.00% 0/19
General disorders Sedation	0.00% 0/39	25.0% 6/24 • Number of events 6	21.1% 4/19 • Number of events 4
General disorders Dizziness	0.00% 0/39	0.00% 0/24	15.8% 3/19 • Number of events 3

Additional Information

Naomi M. Simon, MD

Massachusetts General Hospital

Phone: 617-726-7913

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place