Trial · NCT00118417

Therapies for Treatment-Resistant Panic Disorder Symptoms

NCT00118417, Phase 2, Phase 3, Completed, Massachusetts General Hospital; results first posted 2009-07-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Therapies for Treatment-Resistant Panic Disorder Symptoms. Trials, record NCT00118417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00118417

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Therapies for Treatment-Resistant Panic Disorder Symptoms
NCT number: NCT00118417
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 46 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Panic Disorder
Interventions: Clonazepam, Sertraline, Cognitive behavioral therapy
First posted: 2005-07-11
Last updated: 2014-06-11
Results first posted: 2009-07-28
Limitations and caveats: Power in Phase 2 limited detection to a large effect size. High drop-out for increased SSRI dose may indicate poor tolerability. Effectiveness of adding an SSRI to initial CBT was unexamined, limiting generalization to community treatment decisions.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)	Measured at baseline and after Phase 1 (6 weeks)	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.
Primary	Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)	Measured after Phase 1 (Week 6) and Phase 2 (Week 12)	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.
Primary	Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)	Measured after Phase 2 (Week 12) and Phase 3 (Week 24)	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)	Measured at baseline and after Phase 1 (6 weeks)	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.	Points on a scale	MEAN
PRIMARY	Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)	Measured after Phase 1 (Week 6) and Phase 2 (Week 12)		Points on a scale	MEAN
PRIMARY	Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)	Measured after Phase 2 (Week 12) and Phase 3 (Week 24)		Points on a scale	MEAN

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)	Moderate Sertraline Treatment	4.3	Standard Deviation 4.3	Points on a scale
Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)	Increased Sertraline	2.36	Standard Deviation 3.44	Points on a scale
Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)	Sertraline Plus Placebo	2.31	Standard Deviation 4.29	Points on a scale
Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)	Medication Optimization	3.78	Standard Deviation 3.80	Points on a scale
Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)	Augmented Cognitive Behavior Therapy	2.9	Standard Deviation 3.63	Points on a scale

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase I (Weeks 0 to 6)	STARTED	Sertraline / Increased Dose / Medication Optimization	39
Phase I (Weeks 0 to 6)	STARTED	Sertraline / + Placebo / Cognitive Behavior Therapy Augment.	0
Phase I (Weeks 0 to 6)	COMPLETED	Sertraline / Increased Dose / Medication Optimization	21
Phase I (Weeks 0 to 6)	COMPLETED	Sertraline / + Placebo / Cognitive Behavior Therapy Augment.	0
Phase I (Weeks 0 to 6)	NOT COMPLETED	Sertraline / Increased Dose / Medication Optimization	18
Phase I (Weeks 0 to 6)	NOT COMPLETED	Sertraline / + Placebo / Cognitive Behavior Therapy Augment.	0
Phase II (Weeks 6 to 12)	STARTED	Sertraline / Increased Dose / Medication Optimization	11
Phase II (Weeks 6 to 12)	STARTED	Sertraline / + Placebo / Cognitive Behavior Therapy Augment.	13
Phase II (Weeks 6 to 12)	COMPLETED	Sertraline / Increased Dose / Medication Optimization	9
Phase II (Weeks 6 to 12)	COMPLETED	Sertraline / + Placebo / Cognitive Behavior Therapy Augment.	10

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events33

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Gastrointestinal distress	Gastrointestinal disorders	Phase I: Sertraline	19	39	19
other	Gastrointestinal distress	Gastrointestinal disorders	Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone	7	24	7
other	Gastrointestinal distress	Gastrointestinal disorders	Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam	6	19	6
other	Headache	General disorders	Phase I: Sertraline	16	39	16
other	Headache	General disorders	Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone	7	24	7
other	Headache	General disorders	Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam	6	19	6
other	Nausea or Vomiting	General disorders	Phase I: Sertraline	15	39	15
other	Nausea or Vomiting	General disorders	Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone	0	24	0
other	Nausea or Vomiting	General disorders	Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam	0	19	0
other	Jitteriness or Restlesness	General disorders	Phase I: Sertraline	12	39	12

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I: Sertraline
Total, all-cause mortality	Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone
Total, all-cause mortality	Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam
Total, other adverse events	Phase I: Sertraline	33	39
Total, other adverse events	Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone	21	24
Total, other adverse events	Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam	15	19
Total, serious adverse events	Phase I: Sertraline	2	39
Total, serious adverse events	Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone	0	24
Total, serious adverse events	Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam	3	19

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19814948	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
K23MH001831	TREATMENT REFRACTORY PANIC DISORDER	SIMON, NAOMI M	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL INSTITUTE OF MENTAL HEALTH	2000 to 2004

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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