Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder

• Sponsor: Multidisciplinary Association for Psychedelic Studies (Other)
• Overall Status: Completed
• CT.gov ID: NCT00353938
• Collaborator: Swiss Medical Association for Psycholytic Therapy (Other)
• Enrollment: 14
• Location: 1
• Arms: 2
• Duration (Months): 52
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment. This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy, scheduled three to five weeks apart, can be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms. Participants will be randomly assigned to receive the full dose of MDMA (125 mg) or assigned to receive a low or "active placebo" dose of MDMA (25 mg) during each of three experimental sessions.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder	Drug: 3,4-methylenedioxymethamphetamine (125 mg); Drug: 3,4-methyelendioxymethamphetamine (25 mg); Behavioral: Therapy	Phase 2

Detailed Description

Posttraumatic stress disorder (PTSD) occurs after experiencing a traumatic event or events. PTSD is a public health problem that causes a great deal of suffering.

This study will examine MDMA-assisted psychotherapy in individuals aged 18 years or older diagnosed with PTSD, with PTSD symptoms not improving after trying at least one treatment. This objective of this study is to determine whether three eight-hour long sessions of MDMA-assisted psychotherapy, scheduled three to five weeks apart, can be safely administered to participants with PTSD, and whether combining a fully therapeutic dose of MDMA with psychotherapy, when compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms. Participants will be randomly assigned to receive the full dose of MDMA (125 mg) or assigned to receive a low or "active placebo" dose of MDMA (25 mg) during each of three experimental sessions.

People who receive the low dose of MDMA have the opportunity to take part in a second "open label" study continuation, wherein the participants will undergo three MDMA-assisted sessions, with the participant and the researchers knowing that a full dose of MDMA is being administered. People who receive the full dose of MDMA, and any person who received low-dose MDMA and does not undergo the open-label study continuation will have PTSD symptoms measured six and twelve months after the third session. People who take part in the open label study continuation have their PTSD symptoms assessed six and 12 months after the third Phase II MDMA-assisted session.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase II Pilot Randomized Double-Blind Placebo-Controlled Study of 3,4-methylenedioxymethamphetamine (MDMA)Assisted Psychotherapy in Posttraumatic Stress Disorder (PTSD)- Switzerland
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Full Dose MDMA-assisted therapy (125 mg) Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA	Drug: 3,4-methylenedioxymethamphetamine (125 mg); Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.; Other Names: MDMA ; Behavioral: Therapy; Non-directive therapy performed by a team of two co-therapists
Active Comparator: Active Placebo MDMA-assisted therapy (25 mg) Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA	Drug: 3,4-methyelendioxymethamphetamine (25 mg); Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally.; Other Names: MDMA ; Behavioral: Therapy; Non-directive therapy performed by a team of two co-therapists

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) [Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)]

   The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.

Secondary Outcome Measures

1. Change From Baseline to Primary Endpoint in Posttraumatic Stress Diagnostic Scale (PDS) [Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)]

   The Posstraumatic Stress Diagnostic Scale (PSD) is a 49-item self-report instrument to aid in the diagnosis of PTSD. Questions are asked about symptoms experienced and participants respond on a scale from 0 ("not at all or only one time") to 3 ("5 or more times a week/almost always"). Items are summed to create a total score that ranges from 0 to 51, with higher scores indicating more PTSD symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with posttraumatic stress disorder (PTSD).

• PTSD still remains after one or more prior treatment, with treatment including psychotherapy (talk therapy) or drug therapy

• May meet criteria for a mood disorder

• Must be at least 18 years old

• Must be able to stop taking psychiatric medication during the course of the study, from the start of the study to the follow-up two months after experimental session 3.

• Must agree to follow all rules and instructions relating to the experimental session, including restrictions on food and substance (alcohol and drug) consumption.

• Must be willing to stay overnight at the researcher's office after each experimental session until the non-drug session occurring the next morning.

• Must be willing to be contacted by one of the researchers on a daily basis for a week after each experimental session.

• Female participants of childbearing potential must have a negative pregnancy test and must agree to use an effective form of birth control.

• Participants must have sufficient proficiency in speaking the German language to participate in MDMA-assisted psychotherapy. Participants must be able to read documents in German.

Exclusion Criteria:

• Cannot have history of or current primary psychotic disorder or bipolar affective disorder-1.

• Dissociative identity disorder, or an eating disorder with active purging or borderline personality disorder.

• Evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).

• Uncontrolled hypertension, peripheral vascular disease, hepatic disease (with or without abnormal liver enzymes), or history of hyponatremia or hyperthermia.

• Being pregnant or lactating (nursing), or not practicing an effective method of birth control.

• Weight of less than 50 or more than 105 kg.

• Patients reporting prior use of "Ecstasy" more than 5 times or at any time within the previous 6 months.

• People who would present a serious suicide risk or who are likely to require hospitalization during the course of the study.

• People who need ongoing concomitant therapy with a psychotropic drug.

• Meeting DSM-IV criteria for substance abuse or dependence for any substance save caffeine or nicotine in the past 60 days.

• People who cannot give adequate consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Offices of Peter Oehen MD	Biberist	Solothurn	Switzerland

Sponsors and Collaborators

• Multidisciplinary Association for Psychedelic Studies
• Swiss Medical Association for Psycholytic Therapy

Investigators

• Principal Investigator: Peter Oehen, MD, private practice, Biberist, Switzerland

Study Documents (Full-Text)

• Informed Consent Form - Dec 17, 2007

More Information

Publications

None provided.

• Responsible Party: Multidisciplinary Association for Psychedelic Studies
• ClinicalTrials.gov Identifier: NCT00353938
• Other Study ID Numbers: M-P2
• First Posted: Jul 19, 2006
• Last Update Posted: Jul 6, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by Multidisciplinary Association for Psychedelic Studies: PTSD, MDMA, psychotherapy, Switzerland
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; N-Methyl-3,4-methylenedioxyamphetamine

Study Results

Participant Flow

Recruitment Details	Participants were recruited by calling for referrals from psychiatric hospitals, trauma counseling centers, psychiatrists and psychotherapists in the German-speaking part of Switzerland.
Pre-assignment Detail	Only active control participants from Stage 1 entered into open-label Stage 2 and only participants who received full dose in Stage1 or Stage 2 and did not respond with significant improvement were offered the opportunity to partake in open-label Stage 3.

Arm/Group Title	Full Dose MDMA-assisted Therapy (125 mg Stage 1)	Active Placebo MDMA-assisted Therapy (25 mg Stage 1)	Full Dose MDMA-assisted Therapy (125 mg Stage 2)	Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
Arm/Group Description	Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists	Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA 3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists	Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.	Two 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA, or a 20% larger dose of 150 mg MDMA, followed by a supplemental dose of 75 mg administered 2.5 hours later. 3,4-methylenedioxymethamphetamine (125 or 150 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally or Participants will receive an initial dose of 150 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 75 mg MDMA orally.
Period Title: Stage 1
STARTED	9	5	0	0
COMPLETED	8	5	0	0
NOT COMPLETED	1	0	0	0
Period Title: Stage 1
STARTED	0	0	4	0
COMPLETED	0	0	4	0
NOT COMPLETED	0	0	0	0
Period Title: Stage 1
STARTED	0	0	0	3
COMPLETED	0	0	0	3
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Full Dose MDMA-assisted Therapy (125 mg)	Active Placebo MDMA-assisted Therapy (25 mg)	Total
Arm/Group Description	Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists	Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA 3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists	Total of all reporting groups
Overall Participants	8	4	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.1 (12.8)	40.0 (6.2)	41.4 (11.2)
Sex: Female, Male (Count of Participants)
Female	7 87.5%	3 75%	10 83.3%
Male	1 12.5%	1 25%	2 16.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Country of origin (Count of Participants)
Switzerland	7 87.5%	4 100%	11 91.7%
France	1 12.5%	0 0%	1 8.3%
Work status (Count of Participants)
On disability	4 50%	1 25%	5 41.7%
Fit for limited employment	2 25%	1 25%	3 25%
Working full-time	1 12.5%	2 50%	3 25%
Retired	1 12.5%	0 0%	1 8.3%
Duration of PTSD (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	16.4 (10.9)	22.3 (12.1)	18.3 (12.0)
Duration of prior therapy (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	39.9 (73.3)	123 (60.6)	85.8 (71.4)
On medication for PTSD at enrollment (Count of Participants)
Yes	4 50%	2 50%	6 50%
No	4 50%	2 50%	6 50%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV)
Description	The CAPS-IV is a structured clinical interview designed to assess the symptoms and severity of PTSD. The CAPS-IV provides a means to evaluate the frequency and intensity dimensions of each symptom, the impact of symptoms on the patient's social and occupational functioning, the overall severity of the symptom complex, global improvement since baseline, and the validity of the ratings obtained. Total severity scores range from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Time Frame	Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full Dose MDMA-assisted Therapy (125 mg)	Active Placebo MDMA-assisted Therapy (25 mg)
Arm/Group Description	Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists	Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA 3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists
Measure Participants	8	4
Mean (Standard Deviation) [score on a scale]	-15.6 (18.1)	-3.2 (15.3)

2. Secondary Outcome

Title	Change From Baseline to Primary Endpoint in Posttraumatic Stress Diagnostic Scale (PDS)
Description	The Posstraumatic Stress Diagnostic Scale (PSD) is a 49-item self-report instrument to aid in the diagnosis of PTSD. Questions are asked about symptoms experienced and participants respond on a scale from 0 ("not at all or only one time") to 3 ("5 or more times a week/almost always"). Items are summed to create a total score that ranges from 0 to 51, with higher scores indicating more PTSD symptoms.
Time Frame	Less than 4 weeks before first experimental session (Baseline) to 3 weeks post 3rd experimental session (Primary Endpoint)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full Dose MDMA-assisted Therapy (125 mg)	Active Placebo MDMA-assisted Therapy (25 mg)
Arm/Group Description	Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists	Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA 3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists
Measure Participants	8	4
Mean (Standard Deviation) [score on a scale]	-8.6 (13.0)	7.3 (6.2)

Adverse Events

Time Frame	From baseline to end of Stage 3 (approximately 1 year)
Arm/Group Title	Full Dose MDMA-assisted Therapy (125 mg Stage 1)		Active Placebo MDMA-assisted Therapy (25 mg Stage 1)		Full Dose MDMA-assisted Therapy (125 mg Stage 2)		Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
Arm/Group Description	Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists		Three 8-hour sessions of MDMA-assisted therapy with 25 mg of MDMA, followed by a supplemental dose of 12.5 mg MDMA 3,4-methyelendioxymethamphetamine (25 mg): Participants will receive a 25 mg MDMA orally, and if investigator and participant agree, 2.5 hours later they will receive 12.5 mg MDMA orally. Therapy: Non-directive therapy performed by a team of two co-therapists		Three 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA 3,4-methylenedioxymethamphetamine (125 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally.		Two 8-hour sessions of MDMA-assisted therapy with 125 mg of MDMA, followed by a supplemental dose of 62.5 mg MDMA, or a 20% larger dose of 150 mg MDMA, followed by a supplemental dose of 75 mg administered 2.5 hours later. 3,4-methylenedioxymethamphetamine (125 or 150 mg): Participants will receive an initial dose of 125 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 62.5 mg MDMA orally or Participants will receive an initial dose of 150 mg MDMA orally and, if investigator and participant deem appropriate, 2.5 hours later they will receive 75 mg MDMA orally.
All Cause Mortality
	Full Dose MDMA-assisted Therapy (125 mg Stage 1)		Active Placebo MDMA-assisted Therapy (25 mg Stage 1)		Full Dose MDMA-assisted Therapy (125 mg Stage 2)		Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Serious Adverse Events
	Full Dose MDMA-assisted Therapy (125 mg Stage 1)		Active Placebo MDMA-assisted Therapy (25 mg Stage 1)		Full Dose MDMA-assisted Therapy (125 mg Stage 2)		Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/9 (22.2%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metasteses to central nervous system	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Psychiatric disorders
Suicidal behavior	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Full Dose MDMA-assisted Therapy (125 mg Stage 1)		Active Placebo MDMA-assisted Therapy (25 mg Stage 1)		Full Dose MDMA-assisted Therapy (125 mg Stage 2)		Full or Larger Dose MDMA-assisted Therapy (125 or 150 mg Stage 3)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/9 (88.9%)		3/5 (60%)		2/4 (50%)		1/3 (33.3%)
Ear and labyrinth disorders
Otitis media	0/9 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)
Gastrointestinal disorders
Abdominal Pain	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Diarrhea	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Nausea	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Vomiting	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Abdominal pain lower	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
General disorders
Fatigue	1/9 (11.1%)		2/5 (40%)		1/4 (25%)		1/3 (33.3%)
Pain	0/9 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)
Infections and infestations
Urinary tract infection	0/9 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)
Angina tonsillitus	0/9 (0%)		0/5 (0%)		0/4 (0%)		1/3 (33.3%)
Injury, poisoning and procedural complications
Limb injury	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Investigations
Red blood cell sedimentation rate increased	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Hypothyroidism	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Iron deficiency Anemia	0/9 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)
Musculoskeletal and connective tissue disorders
Muscle spasms	0/9 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)
Neck pain	0/9 (0%)		0/5 (0%)		1/4 (25%)		0/3 (0%)
Nervous system disorders
Dizziness	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Headache	1/9 (11.1%)		1/5 (20%)		1/4 (25%)		0/3 (0%)
Visual acuity reduced	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Psychiatric disorders
Panic attack	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Anxiety	4/9 (44.4%)		1/5 (20%)		0/4 (0%)		0/3 (0%)
Depressed mood	2/9 (22.2%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Disturbance in attention	2/9 (22.2%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Insomnia	2/9 (22.2%)		1/5 (20%)		1/4 (25%)		0/3 (0%)
Somatoform disorder	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Somnolence	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Tension	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Intentional self-injury	0/9 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Pneumonia	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Pneumonia chlamydial	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Bronchial disorder	0/9 (0%)		1/5 (20%)		0/4 (0%)		0/3 (0%)
Skin and subcutaneous tissue disorders
Psoriasis	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)
Vascular disorders
Hypertension	1/9 (11.1%)		0/5 (0%)		0/4 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.