Panic DisorderPhase 2NCT00725725
Org 25935 Versus Placebo as Augmentation to Cognitive-behavioral Therapy to Treat Panic Disorder (P05705)
A Phase 2 study testing Cognitive-behavioral therapy and Org 25935 in people with Panic Disorder, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Cognitive-behavioral therapy and Org 25935
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 23 Jul 2008to 23 Apr 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: A Multi-center, Double-blind, Fixed Dose Trial Examining the Efficacy and Safety of Org 25935 Versus Placebo as Augmentation to Cognitive Behavioral Therapy in Subjects With Panic Disorder
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
- Panic Disorder
- Being tested
- Cognitive-behavioral therapy, Org 25935, Placebo
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapyBehavioural
Participants underwent 5 weekly CBT session (sessions were 60-90 minutes in duration).
Org 25935Drug
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.
Org 25935Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 4 mg Org 25935 | Experimental | Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period. Receives: Behavioral: Cognitive-behavioral therapy; Drug: Org 25935 |
| 12 mg Org 25935 | Experimental | Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period. Receives: Behavioral: Cognitive-behavioral therapy; Drug: Org 25935 |
| Placebo | Placebo comparator | Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period. Receives: Behavioral: Cognitive-behavioral therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Screening and Day 36
Secondary outcomes (11)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study start23 Jul 2008
- Primary completion23 Apr 2010
- Study completion23 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725725
- Sponsor's protocol ID
- P05705
- Other IDs
- MK-8435-002, Org 172012
- Status last verified
- Sep 2018
- First submitted
- 28 Jul 2008
- Last updated
- 16 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Fixed Dose Trial Examining the Efficacy and Safety of Org 25935 Versus Placebo as Augmentation to Cognitive Behavioral Therapy in Subjects With Panic Disorder
- ClinicalTrials.gov ID
- NCT00725725
- Acronym / sponsor ID
- P05705
- Conditions
- Panic Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2008 (actual)
- Primary completion
- 23 Apr 2010 (actual)
- Study completion
- 23 Apr 2010 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Posted 30 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4 mg Org 25935 | Experimental | Behavioral: Cognitive-behavioral therapy, Drug: Org 25935Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period. |
| 12 mg Org 25935 | Experimental | Behavioral: Cognitive-behavioral therapy, Drug: Org 25935Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period. |
| Placebo | Placebo comparator | Behavioral: Cognitive-behavioral therapy, Drug: PlaceboParticipants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapyParticipants underwent 5 weekly CBT session (sessions were 60-90 minutes in duration). | Behavioural | 12 mg Org 25935, 4 mg Org 25935, Placebo |
| Org 259354 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. | Drug | 4 mg Org 25935 |
| Org 2593512 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. | Drug | 12 mg Org 25935 |
| PlaceboPlacebo 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. | Drug | Placebo |
Primary outcome
Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)
Time frame: 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).
11 secondary outcomes
Change in PDSS Score From Baseline to Visit 4
Time frame: Screening and Visit 4 (Day 22)
Change in PDSS Score From Baseline to Follow-Up
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
Time frame: Screening
SCID-I/P With Psy Screen Score at EOT
Time frame: Day 36
Change in Clinical Global Impression-Severity (CGI-S) Score
Time frame: Screening and Day 36
Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score
Time frame: Screening and Day 36
Change in Anxiety Sensitivity Index (ASI) Score
Time frame: Screening and Day 36
Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score
Time frame: Screening and Day 36
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score
Time frame: Screening and Day 36
Number of Participants Experiencing an Adverse Event (AE)
Time frame: Up to 59 days
Number of Participants Discontinuing Study Therapy Due to AEs
Time frame: Up to 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22394471Nations 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.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive-behavioral therapy and Org 25935 in people with Panic Disorder, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT) (time frame: Screening and Day 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00725725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.