Trial · NCT00725725

Org 25935 Versus Placebo as Augmentation to Cognitive-behavioral Therapy to Treat Panic Disorder (P05705)

NCT00725725, Phase 2, Terminated, Merck Sharp & Dohme LLC; results first posted 2016-12-30

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Org 25935 Versus Placebo as Augmentation to Cognitive-behavioral Therapy to Treat Panic Disorder (P05705). Trials, record NCT00725725. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00725725

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Trial

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

Title: Org 25935 Versus Placebo as Augmentation to Cognitive-behavioral Therapy to Treat Panic Disorder (P05705)
NCT number: NCT00725725
Status: Terminated
Phases: Phase 2
Enrollment: 46 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Panic Disorder
Interventions: Cognitive-behavioral therapy, Org 25935, Org 25935, Placebo
First posted: 2008-07-30
Last updated: 2018-10-16
Results first posted: 2016-12-30

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)	Screening and Day 36	The mean change in PDSS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).
Secondary	Change in PDSS Score From Baseline to Visit 4	Screening and Visit 4 (Day 22)	The mean change in PDSS score from baseline (Screening) to Visit 4 (Day 22) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).
Secondary	Change in PDSS Score From Baseline to Follow-Up	Screening and Follow-Up (Day 59)	The mean change in PDSS score from baseline (Screening) to Follow-Up (Day 59) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).
Secondary	Structured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at Screening	Screening	The SCID-I/P with Psy Screen, Panic Disorder Module was used to score participants' PD (with \[w\] or without \[w/o\] AGP) as being current (full criteria for the disorder met), in full remission (IFR) \[there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder\], or in partial remission (IPR) \[full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain\] at baseline (Screening). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.
Secondary	SCID-I/P With Psy Screen Score at EOT	Day 36	The SCID-I/P with Psy Screen, Panic Disorder Module, was used to score participants' PD (w or w/o AP) as being current (full criteria for the disorder are met), IFR (there are no longer any symptoms or signs of the disorder, but it is still clinically relevant to note the disorder), or IPR (full criteria for the disorder were previously met, but currently only some of the symptoms or signs of the disorder remain) at EOT (Day 36). The SCID-I/P is a diagnostic exam used to assess for Axis-1 mental disorders.
Secondary	Change in Clinical Global Impression-Severity (CGI-S) Score	Screening and Day 36	The mean change in CGI-S score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The CGI-S is a clinician-rated instrument used to assess global severity of general anxiety symptoms. The instrument consists of a 7-point scale that the clinician uses to rate the severity of the patient's illness, from 1 (normal, not at all ill) to 7 (extremely ill).
Secondary	Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score	Screening and Day 36	The mean change in SIGH-A score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The SIGH-A is a 14-item scale to assess anxiety in a clinical population. Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of zero to a maximum of 56 (higher scores indicate greater anxiety severity).
Secondary	Change in Anxiety Sensitivity Index (ASI) Score	Screening and Day 36	The mean change in ASI score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The ASI is a 16-item self-report questionnaire that assesses fear of anxiety sensations. Each item is scored on a 5-point Likert scale (0 to 4) with total score ranging from a minimum of 0 to a maximum of 64 (higher scores indicate greater fear of anxiety sensations).
Secondary	Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score	Screening and Day 36	The mean change in MADRS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The MADRS is a 10-item clinical-administered scale designed to assess severity of depression. Each item is rated from 0 to 6, with total score ranging from 0 to 60 (higher MADRS scores indicate more severe depression).
Secondary	Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score	Screening and Day 36	The mean change in Q-LES-Q score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The Q-LES-Q is a self-report questionnaire rating 16 aspects of quality of life, including physical health and mood. Scores range from 0 ("very poor") to 5 ("very good"), with total score ranging from 0 to 80 (higher O-LES-Q scores indicate greater quality of life).

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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 Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)	Screening and Day 36	The Intent-to-Treat (ITT) population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS assessments at Screening and EOT.	PDSS Score	MEAN
SECONDARY	Change in PDSS Score From Baseline to Visit 4	Screening and Visit 4 (Day 22)	The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and PDSS scores at Screening and Visit 4.	PDSS Score	MEAN
SECONDARY	Change in PDSS Score From Baseline to Follow-Up	Screening and Follow-Up (Day 59)	The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had PDSS scores at Screening and Follow-Up.	PDSS Score	MEAN
SECONDARY	Structured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at Screening	Screening	The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at Screening.	Participants	NUMBER
SECONDARY	SCID-I/P With Psy Screen Score at EOT	Day 36	The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SCID-I/P with Psy Screen scores at EOT.	Participants	NUMBER
SECONDARY	Change in Clinical Global Impression-Severity (CGI-S) Score	Screening and Day 36	The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had CGI-S scores at Screening and EOT.	CGI-S Score	MEAN
SECONDARY	Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score	Screening and Day 36	The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had SIGH-A scores at Screening and EOT.	SIGH-A Score	MEAN
SECONDARY	Change in Anxiety Sensitivity Index (ASI) Score	Screening and Day 36	The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had ASI scores at Screening and EOT.	ASI Score	MEAN
SECONDARY	Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score	Screening and Day 36	The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had MADRS scores at Screening and EOT.	MADRS score	MEAN
SECONDARY	Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score	Screening and Day 36	The ITT population consisted of all participants who received ≥1 dose of double-blind study medication and had Q-LES-Q scores at Screening and EOT.	Q-LES-Q Score	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group102

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

Outcome	Group	Category	Value	Spread	Units
Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)	4 mg Org 25935	Screening	11.5	Standard Deviation 1.51	PDSS Score
Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)	12 mg Org 25935	Screening	15.8	Standard Deviation 4.00	PDSS Score
Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)	Placebo	Screening	17.1	Standard Deviation 3.99	PDSS Score
Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)	4 mg Org 25935	EOT (Placebo n=12)	5.3	Standard Deviation 1.49	PDSS Score
Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)	12 mg Org 25935	EOT (Placebo n=12)	7.6	Standard Deviation 4.62	PDSS Score
Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)	Placebo	EOT (Placebo n=12)	6.6	Standard Deviation 4.29	PDSS Score
Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)	4 mg Org 25935	EOT - Screening (Placebo n=12)	-6.2	Standard Deviation 2.15	PDSS Score
Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)	12 mg Org 25935	EOT - Screening (Placebo n=12)	-8.2	Standard Deviation 4.49	PDSS Score
Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)	Placebo	EOT - Screening (Placebo n=12)	-10.4	Standard Deviation 4.23	PDSS Score
Change in PDSS Score From Baseline to Visit 4	4 mg Org 25935	Screening	11.5	Standard Deviation 1.51	PDSS Score

1 to 10 of 102Source ClinicalTrials.gov

See all 102 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	4 mg Org 25935	14
Overall Study	STARTED	12 mg Org 25935	15
Overall Study	STARTED	Placebo	17
Overall Study	Treated	4 mg Org 25935	11
Overall Study	Treated	12 mg Org 25935	15
Overall Study	Treated	Placebo	14
Overall Study	COMPLETED	4 mg Org 25935	10
Overall Study	COMPLETED	12 mg Org 25935	11
Overall Study	COMPLETED	Placebo	12
Overall Study	NOT COMPLETED	4 mg Org 25935	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events144

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	Neutropenia	Blood and lymphatic system disorders	Org 25935 4 mg	1	11	1
other	Neutropenia	Blood and lymphatic system disorders	Org 25935 12 mg	0	15	0
other	Neutropenia	Blood and lymphatic system disorders	Placebo	0	14	0
other	Palpitations	Cardiac disorders	Org 25935 4 mg	1	11	1
other	Palpitations	Cardiac disorders	Org 25935 12 mg	0	15	0
other	Palpitations	Cardiac disorders	Placebo	0	14	0
other	Tachycardia	Cardiac disorders	Org 25935 4 mg	0	11	0
other	Tachycardia	Cardiac disorders	Org 25935 12 mg	1	15	1
other	Tachycardia	Cardiac disorders	Placebo	0	14	0
other	Tinnitus	Ear and labyrinth disorders	Org 25935 4 mg	1	11	1

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Org 25935 4 mg
Total, all-cause mortality	Org 25935 12 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Org 25935 4 mg	8	11
Total, other adverse events	Org 25935 12 mg	12	15
Total, other adverse events	Placebo	5	14
Total, serious adverse events	Org 25935 4 mg	0	11
Total, serious adverse events	Org 25935 12 mg	0	15
Total, serious adverse events	Placebo	0	14

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22394471	DERIVED

Source PubMed

Grants0

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.

None in this release.

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.

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