TerminatedNCT00725725Updated Oct 16, 2018Results posted

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

A Phase 2 interventional study of Cognitive-behavioral therapy and Org 25935 in Panic Disorder, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-16.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 46
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

The purpose of this study is to evaluate the effectiveness of Org 25935 vs. placebo given in combination with cognitive-behavioral therapy (CBT) to reduce the symptoms of panic disorder. It is hypothesized that treatment with Org 25935 at a dose of 4 mg or 12 mg will differ significantly from placebo with respect to the Panic Disorder Severity Scale (PDSS) total score over 3 weeks of therapy.

Conditions studied

Panic Disorder

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Panic Disorder 250

In context

Panic Disorder

250 studies on the registry are indexed under Panic Disorder; 35 are open to participants now.

This study's enrollment of 46 is below the median of 80 across 195 interventional studies indexed under Panic Disorder.

Browse Panic Disorder studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

is a male, or a female who is not of childbearing potential or who is non-pregnant, non-lactating and using a medically accepted method of contraception.
is between the ages of 18 and 65, inclusive;
signed written informed consent after the scope and nature of the investigation have been explained to them before Screening evaluations;
is fluent in English;
is diagnosed at Screening with current panic disorder, with or without agoraphobia;
has a Clinical Global Impressions (CGI)-Severity score at Screening of >= 4 and \<= 6;
is currently taking no psychotropic medications or is able and willing to discontinue these medications prior to the first CBT session. Anti-depressant and anxiolytic medications are acceptable only if they are stabilized for at least 8 weeks prior to Screening;
is able to complete all scheduled assessment and treatment visits and is willing to comply with the requirements of the study protocol.

Exclusion criteria

Exclusion Criteria:

is diagnosed with a primary Axis I disorder other than panic disorder;
has a Screening Montgomery-Asberg Depression Rating Scale (MADRS) score of >= 35 (severe depression);
has any history of bipolar disorder, psychotic disorder, or obsessive compulsive disorder;
has a diagnosis of post traumatic stress disorder, eating disorder, or substance abuse or dependence (excluding nicotine) within the past six months;
is known or suspected to have significant personality dysfunction that could, in the investigator's opinion, interfere with trial participation. Participants with known borderline or avoidant personality disorder are excluded;
are at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (C-SSRS). Participants must be excluded if they report suicidal ideation of Type 4 or 5 in the past 3 months or suicidal behavior in the past 12 months as measured by the C-SSRS at Screening;
is currently a psychiatric inpatient or has been hospitalized for a psychiatric condition within the past year;
has ever been diagnosed with organic brain syndrome, mental retardation, or other cognitive dysfunction that could interfere with their capacity to participate in CBT or to complete safety and efficacy assessments;
has any history of head trauma causing ongoing cognitive impairment;
has any history of seizures (apart from childhood febrile seizures);
has an uncontrolled, unstable clinically significant medical condition (e.g., renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, or malignancy) that may interfere with the interpretation of safety and efficacy evaluations in the opinion of the investigator;
has a clinically relevant visual disturbance, such as cataract, color blindness, macular degeneration, glaucoma, or retinal disease;
has clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at Screening that may interfere with the interpretation of safety or efficacy assessments in the opinion of the investigator;
has a Corrected QT interval (QTc) value >450 milliseconds at Screening using Bazett's QTc formula;
for females, has a positive result on serum pregnancy test (at Screening), or plan to become pregnant during the course of the trial;
has a positive urine drug or alcohol breath test at Screening, unless the positive finding can be accounted for by documented prescription use;
is unable or unwilling to comply with the investigator's instructions regarding drug and alcohol use during the trial period;
has a history of sensitivity/idiosyncrasy to glutamatergic drugs or chemically related compounds or excipients which may be employed in the trial or to any other unknown drug used in the past;
are receiving concurrent psychotherapy for the treatment of panic disorder [general supportive psychotherapy is acceptable if therapy was initiated at least 3 months prior to Screening] or have received a prior adequate trial of CBT for panic disorder;
has been exposed to an investigational drug within 6 months prior to Screening.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 46 participants (actual)

Study arms

Experimental
4 mg Org 25935
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Behavioral: Cognitive-behavioral therapy · Drug: Org 25935
Experimental
12 mg Org 25935
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Behavioral: Cognitive-behavioral therapy · Drug: Org 25935
Placebo comparator
Placebo
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Behavioral: Cognitive-behavioral therapy · Drug: Placebo

Interventions

BehavioralCognitive-behavioral therapy
Participants underwent 5 weekly CBT session (sessions were 60-90 minutes in duration).
DrugOrg 25935
4 mg Org 25935 is given in tablet form, a single dose 2 hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a 2-week period.
DrugOrg 25935
12 mg Org 25935 is given in tablet form, a single dose two hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a two-week period.
DrugPlacebo
Placebo is given in tablet form, a single dose 2 hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a 2-week period.

What researchers measure

Primary outcomes

Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)
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).
Time frame: Screening and Day 36

Secondary outcomes

Change in PDSS Score From Baseline to Visit 4
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).
Time frame: Screening and Visit 4 (Day 22)
Change in PDSS Score From Baseline to Follow-Up
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).
Time frame: Screening and Follow-Up (Day 59)
Structured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at 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.
Time frame: Screening
SCID-I/P With Psy Screen Score at EOT
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.
Time frame: Day 36
Change in Clinical Global Impression-Severity (CGI-S) Score
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).
Time frame: Screening and Day 36
Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score
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).
Time frame: Screening and Day 36
Change in Anxiety Sensitivity Index (ASI) Score
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).
Time frame: Screening and Day 36
Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score
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).
Time frame: Screening and Day 36
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score
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).
Time frame: Screening and Day 36
Number of Participants Experiencing an Adverse Event (AE)
The number of participants experiencing one or more AEs throughout the study period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 59 days
Number of Participants Discontinuing Study Therapy Due to AEs
The number of participants withdrawing from study treatment during the treatment period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 2 weeks

Results

Posted Dec 30, 2016

Participant flow

Adult (18 to 65 years of age) male and female participants with a diagnosis of current panic disorder (PD; with or without agoraphobia \[AGP\]) were recruited.

Participant flow — Overall Study
Milestone	4 mg Org 25935	12 mg Org 25935	Placebo
Started	14	15	17
Treated	11	15	14
Completed	10	11	12
Not completed	4	4	5
Withdrew: Adverse event	1	3	2
Withdrew: Lost to follow-up	2	0	2
Withdrew: Withdrawal by subject	1	0	1
Withdrew: Protocol violation	0	1	0

Outcome measures

PrimaryChange in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)

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).

Time frame:: Screening and Day 36
Reported as:: Mean · PDSS Score

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

Statistical analysis

4 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.3934 · Mean difference (final values): 1.5299 · 95% CI -2.0781 to 5.1380
12 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.3515 · Mean difference (final values): 1.2667 · 95% CI -1.4665 to 4.0000

SecondaryChange in PDSS Score From Baseline to Visit 4

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).

Time frame:: Screening and Visit 4 (Day 22)
Reported as:: Mean · PDSS Score

Change in PDSS Score From Baseline to Visit 4
PDSS Score	4 mg Org 25935	12 mg Org 25935	Placebo
Screening	11.5 ± 1.51	15.8 ± 4.00	17.1 ± 3.99
Visit 4 (4 mg O n= 9; 12 mg O n=12)	7.1 ± 4.08	10.5 ± 4.56	12.2 ± 4.00
Visit 4 - Screening (4 mg O n= 9; 12 mg O n=12)	-4.2 ± 3.70	-5.3 ± 4.03	-4.9 ± 4.52

Statistical analysis

4 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.3597 · Mean difference (final values): -1.8246 · 95% CI -5.8307 to 2.1815
12 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.7770 · Mean difference (final values): -0.4414 · 95% CI -3.5952 to 2.7124

SecondaryChange in PDSS Score From Baseline to Follow-Up

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).

Time frame:: Screening and Follow-Up (Day 59)
Reported as:: Mean · PDSS Score

Change in PDSS Score From Baseline to Follow-Up
PDSS Score	4 mg Org 25935	12 mg Org 25935	Placebo
Screening	11.5 ± 1.51	15.8 ± 4.00	17.1 ± 3.99
Follow-Up (12 mg O, Placebo n=12)	4.8 ± 2.20	7.4 ± 5.85	5.3 ± 4.56
Follow-Up - Screening (12 mg O, Placebo n=12)	-6.7 ± 2.54	-8.3 ± 5.80	-11.7 ± 4.23

Statistical analysis

4 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.2683 · Mean difference (final values): 2.3356 · 95% CI -1.8933 to 6.5644
12 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.0844 · Mean difference (final values): 3.1317 · 95% CI -0.4518 to 6.7152

SecondaryStructured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at 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.

Time frame:: Screening
Reported as:: Number · Participants

Structured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at Screening
Participants	4 mg Org 25935	12 mg Org 25935	Placebo
PD w AGP: Current	9	12	12
PD w/o AGP: Current	1	2	1

SecondarySCID-I/P With Psy Screen Score at EOT

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.

Time frame:: Day 36
Reported as:: Number · Participants

SCID-I/P With Psy Screen Score at EOT
Participants	4 mg Org 25935	12 mg Org 25935	Placebo
PD w AGP: Current	3	4	6
PD w AGP: IFR	0	1	0
PD w AGP: IPR	4	4	5
PD w/o AGP: Current	1	3	0
PD w/o AGP: IFR	0	0	1
PD w/o AGP: IPR	2	1	0

SecondaryChange in Clinical Global Impression-Severity (CGI-S) Score

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).

Time frame:: Screening and Day 36
Reported as:: Mean · CGI-S Score

Change in Clinical Global Impression-Severity (CGI-S) Score
CGI-S Score	4 mg Org 25935	12 mg Org 25935	Placebo
Screening	4.0 ± 0.0	4.6 ± 0.74	4.8 ± 0.83
EOT (Placebo n=12)	2.8 ± 0.42	3.1 ± 0.92	3.0 ± 1.13
EOT - Screening (Placebo n=12)	-1.2 ± 0.42	-1.6 ± 0.85	-1.8 ± 0.97

SecondaryChange in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score

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).

Time frame:: Screening and Day 36
Reported as:: Mean · SIGH-A Score

Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score
SIGH-A Score	4 mg Org 25935	12 mg Org 25935	Placebo
Screening	17.2 ± 8.42	14.3 ± 6.37	14.6 ± 9.14
EOT (12 mg O n=13; Placebo n=12)	9.7 ± 7.21	10.0 ± 6.43	8.5 ± 6.96
EOT - Screening (12 mg O n=13; Placebo n=12)	-7.5 ± 7.37	-3.8 ± 5.97	-6.4 ± 7.62

Statistical analysis

4 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.8894 · Mean difference (final values): 0.3456 · 95% CI -4.6211 to 5.3124
12 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.3765 · Mean difference (final values): 2.0417 · 95% CI -2.5526 to 6.6360

SecondaryChange in Anxiety Sensitivity Index (ASI) Score

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).

Time frame:: Screening and Day 36
Reported as:: Mean · ASI Score

Change in Anxiety Sensitivity Index (ASI) Score
ASI Score	4 mg Org 25935	12 mg Org 25935	Placebo
Screening	31.1 ± 9.92	37.1 ± 9.56	37.5 ± 12.91
EOT (12 mg O n=13)	20.1 ± 10.29	26.3 ± 10.56	24.8 ± 13.95
EOT - Screening (Placebo n=11)	-11.0 ± 10.23	-10.8 ± 14.48	-13.8 ± 13.58

Statistical analysis

4 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.8073 · Mean difference (final values): -1.2502 · 95% CI -11.4963 to 8.9958
12 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.6610 · Mean difference (final values): 2.0291 · 95% CI -7.2132 to 11.2714

SecondaryChange in Montgomery-Asberg Rating Scale for Depression (MADRS) Score

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).

Time frame:: Screening and Day 36
Reported as:: Mean · MADRS score

Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score
MADRS score	4 mg Org 25935	12 mg Org 25935	Placebo
Screening	12.4 ± 8.03	11.1 ± 6.38	14.2 ± 9.20
EOT (12 mg O n=13, Placebo n=12)	6.6 ± 4.33	7.0 ± 6.98	6.3 ± 5.12
EOT - Screening (12 mg O n=13, Placebo n=12)	-5.8 ± 6.76	-4.2 ± 5.06	-7.8 ± 8.53

Statistical analysis

4 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.7895 · Mean difference (final values): 0.7296 · 95% CI -4.7291 to 6.1883
12 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.5488 · Mean difference (final values): 1.5260 · 95% CI -3.5495 to 6.6015

SecondaryChange in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score

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).

Time frame:: Screening and Day 36
Reported as:: Mean · Q-LES-Q Score

Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score
Q-LES-Q Score	4 mg Org 25935	12 mg Org 25935	Placebo
Screening	49.8 ± 6.20	47.2 ± 8.88	45.3 ± 11.63
EOT (12 mg O n=11)	56.6 ± 3.20	50.5 ± 9.32	55.3 ± 7.69
EOT - Screening (12 mg O n=11, Placebo n=11)	6.8 ± 5.39	3.7 ± 5.06	10.8 ± 11.79

Statistical analysis

4 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.6516 · Mean difference (final values): -1.2766 · 95% CI -6.9269 to 4.3738
12 mg Org 25935 vs Placebo · Mixed Models Analysis · p = 0.0256 · Mean difference (final values): -6.1867 · 95% CI -11.5864 to -0.7869

SecondaryNumber of Participants Experiencing an Adverse Event (AE)

The number of participants experiencing one or more AEs throughout the study period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Time frame:: Up to 59 days
Reported as:: Number · Participants

Number of Participants Experiencing an Adverse Event (AE)
Participants	4 mg Org 25935	12 mg Org 25935	Placebo
Number of Participants Experiencing an Adverse Event (AE)	8	12	5

SecondaryNumber of Participants Discontinuing Study Therapy Due to AEs

The number of participants withdrawing from study treatment during the treatment period was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Time frame:: Up to 2 weeks
Reported as:: Number · Participants

Number of Participants Discontinuing Study Therapy Due to AEs
Participants	4 mg Org 25935	12 mg Org 25935	Placebo
Number of Participants Discontinuing Study Therapy Due to AEs	1	3	1

Adverse events

Collected over Up to 59 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Org 25935 4 mg	—	0/11 (0%)	8/11 (72.7%)
Org 25935 12 mg	—	0/15 (0%)	12/15 (80%)
Placebo	—	0/14 (0%)	5/14 (35.7%)

Most frequent other events

Showing 10 of 48

Most frequent other events
Event	Org 25935 4 mg	Org 25935 12 mg	Placebo
DizzinessNervous system disorders	2/11	7/15	0/14
NauseaGastrointestinal disorders	0/11	5/15	0/14
Visual impairmentEye disorders	1/11	4/15	0/14
HeadacheNervous system disorders	1/11	4/15	0/14
VertigoEar and labyrinth disorders	0/11	3/15	0/14
Vision blurredEye disorders	0/11	2/15	1/14
Visual brightnessEye disorders	0/11	2/15	0/14
DiarrhoeaGastrointestinal disorders	0/11	2/15	0/14
FatigueGeneral disorders	1/11	2/15	1/14
DerealisationPsychiatric disorders	0/11	2/15	0/14

Baseline characteristics

Age, Continuous
Age, Continuous(years)	4 mg Org 25935	12 mg Org 25935	Placebo	Total
Mean	33.1 ± 9.9	36.4 ± 8.9	32.8 ± 10.8	34.1 ± 9.9

Sex: Female, Male
Sex: Female, Male(Participants)	4 mg Org 25935	12 mg Org 25935	Placebo	Total
Female	9	9	13	31
Male	5	6	4	15

Study locations

No study locations are listed for this record.

References and documents

Publications

Nations KR, Smits JA, Tolin DF, Rothbaum BO, Hofmann SG, Tart CD, Lee A, Schipper J, Sjogren M, Xue D, Szegedi A, Otto MW. Evaluation of the glycine transporter inhibitor Org 25935 as augmentation to cognitive-behavioral therapy for panic disorder: a multicenter, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2012 May;73(5):647-53. doi: 10.4088/JCP.11m07081. Epub 2012 Feb 21. PubMed 22394471 ↗

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00725725
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Jul 30, 2008
Start date: Jul 23, 2008
Primary completion: Apr 23, 2010
Completion: Apr 23, 2010
Results posted: Dec 30, 2016
Last update: Oct 16, 2018

Study contacts

Medical Director

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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

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Panic Disorder

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