Einleitung wieder einblenden
NCT03153579 | SNCTP000002404

LSD-Behandlung bei Patienten mit Angst

Datenbasis: BASEC (Import vom 22.01.2018), WHO (Import vom 21.01.2018)
Geändert: 12.01.2018
Krankheitskategorie: Anderes

Zusammenfassende Beschreibung der Studie (Datenquelle: BASEC)

Ziel der Studie
Wir möchten Sie hiermit bitten, an unserer Klinischen Studie „LSD-Behandlung bei Patienten mit Angst“ teilzunehmen. Die Studie untersucht die Wirksamkeit von LSD-assistierter im Vergleich zu Placebo-assistierter Psychotherapie bei Patienten mit einer Angststörung. Wir machen diese Studie, um die Wirkung von LSD-unterstützter Psychotherapie bei Patienten mit Angstsymptomen bei schweren somatischen Erkrankungen oder bei psychiatrischen Angststörungen zu untersuchen.
Auswahl
Sie leiden an Angst im Zusammenhang mit einer lebensbedrohlichen Krankheit oder an einer Angststörung. Deshalb lassen wir Ihnen diese Informationsschrift zukommen.
Allgemeine Informationen zur Studie
Psychedelika (Halluzinogene) können möglicherweise gewisse psychische Leiden lindern. Die Studie untersucht die Wirkung von LSD-assistierter gegenüber Placebo-assistierter Psychotherapie auf Angst und Depression. An dieser Studie werden insgesamt 40 Patienten teilnehmen. Die Studie wird gemäss den geltenden Schweizer Gesetzen und international anerkannten Grundsätzen durchgeführt. Die Studie wurde von der lokalen Ethikkommission, dem Schweizerischen Heilmittelinstitut Swissmedic und dem Bundesamt für Gesundheit (BAG) genehmigt.
Ablauf
Insgesamt dauert die Studie 52 Wochen und umfasst eine Eintrittsuntersuchung à 2 h, vier Studientage à 12 h, mindestens 10 Visiten à 1h, und eine Abschlussuntersuchung à 1h.

Untersuchte Krankheiten (Datenquelle: BASEC)

Die Studie untersucht die Wirksamkeit von LSD-assistierter im Vergleich zu Placebo-assistierter Psychotherapie bei Patienten mit einer Angststörung. Wir machen diese Studie, um die Wirkung von LSD-unterstützter Psychotherapie bei Patienten mit Angstsymptomen bei schweren somatischen Erkrankungen oder bei psychiatrischen Angststörungen zu untersuchen.

Health conditions (Datenquelle: WHO)

Patients;Anxiety Disorders;Patients;Anxiety Disorders;Patients;Anxiety Disorders;Patients;Anxiety Disorders

Seltene Krankheit (Datenquelle: BASEC)

Nein

Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne) (Datenquelle: BASEC)

Im Rahmen einer klinischen Studie vergleichen wir die Wirkung von einer psychiatrischen Psychotherapie über 6 Monate ergänzt mit zwei Sitzungen mit einer psychedelischen Substanz (LSD) im Vergleich zu 6 Monate ergänzt mit zwei Situngen mit Placebo auf Angst und Depression. Alle Patienten erhalten die Substanz und Placebo, aber in unterschiedlicher Reihenfolge.

Interventions (Datenquelle: WHO)

Drug: LSD;Drug: Placebo;Drug: LSD;Drug: Placebo;Drug: LSD;Drug: Placebo;Drug: LSD;Drug: Placebo

Kriterien zur Teilnahme an der Studie (Datenquelle: BASEC)

Sie sind über 25 Jahre alt
Sie leiden an Angst im Zusammenhang mit einer lebensbedrohlichen Krankheit oder an einer Angststörung
Das Pausieren von Medikamenten gegen Depression und Angst ist möglich
Sie litten nie an einer psychotischen Störung und haben keine Fälle davon in ihrem erstgradigen Verwandtenkreis
Sie litten nie an einer bipolaren Störung und haben keine Fälle davon in ihrem erstgradigen Verwandtenkreis
Sie leiden nicht an einer schweren Herzkrankheit, unkontrolliertem Bluthochdruck, schwer eingeschränkter Nieren- oder Leberfunktion oder Krebs im Gehirn.
Sie sind nicht stark untergewichtig (<45 kg)
Es besteht kein Risiko für Suizid oder psychiatrische Hospitalisierung
Sie sind nicht unmittelbar vor dem Sterben
Frauen: Sie sind nicht schwanger/stillend und bereit, während der Studie eine doppelte Schwangerschafts-Verhütungsmethode anzuwenden

Ausschlusskriterien (Datenquelle: BASEC)

-

Inclusion/Exclusion Criteria (Datenquelle: WHO)


Inclusion Criteria:

1. Age > 25 years.

2. Meet DSM-IV criteria for anxiety disorder as indicated by the Structured Clinical
Interview for the DSM (SCID)-IV or have a score of at least 40 on the state- or trait
STAI scale at study inclusion.

3. 40% or more of the participants should have a diagnosis of advanced-stage potentially
fatal illness (autoimmune, neurological, or cancer without central nervous system
(CNS) involvement). Patients should be ambulatory and not terminal and likely to have
a roughly estimated life expectancy of > twelve months.

4. Patients without advanced-stage potentially fatal illness need to meet DSM-IV criteria
for anxiety disorder (elevated STAI score not sufficient for inclusion)

5. Sufficient understanding of the study procedures and risks associated with the study.

6. Participants must be willing to adhere to the study procedures and sign the consent
form.

7. Participants are willing to refrain from taking any psychiatric medications during the
experimental session period. If they are being treated with antidepressants or are
taking anxiolytic medications on a fixed daily regimen such drugs must be discontinued
long enough before the LSD/placebo treatment session to avoid the possibility of a
drug-drug interaction (the interval will be at least 5 times the particular drug's
half-life [typically 3-7 days]).

8. If in ongoing psychotherapy, those recruited into the study may continue to see their
outside therapist, provided they sign a release for the investigators to communicate
directly with their therapist. Participants should not change therapists, increase or
decrease the frequency of therapy or commence any new type of therapy during the study
(not including the follow-up).

9. Participants must also refrain from the use of any psychoactive drugs, with the
exception of the long term pain medication or caffeine or nicotine, within 24 hours of
each LSD/placebo treatment session. They must agree not to use nicotine for at least 2
hours before and 6 hours after each dose of LSD. They must agree to not ingest
alcohol-containing beverages for at least 1 day before each LSD treatment session.
Non-routine medications for treating breakthrough pain taken in the 24 hours before
the LSD treatment session may result in rescheduling the treatment session to another
date, with the decision at the discretion of the investigators after discussion with
the participant.

10. Participants must be willing not to drive a traffic vehicle or to operate machines
within 24 h after LSD/placebo administration.

Exclusion Criteria:

1. Women who are pregnant or nursing, or of child bearing potential and are not
practicing an effective means of birth control (double-barrier method, i.e.
pill/intrauterine device and preservative/diaphragm).

2. Past or present diagnosis of a primary psychotic disorder. Subjects with a first
degree relative with psychotic disorders are also excluded.

3. Past or present bipolar disorder (DSM-IV)

4. Current substance use disorder (within the last 2 months, DSM-V, except nicotine)

5. Somatic disorders including central nervous system (CNS) involvement of the cancer,
severe cardiovascular disease, untreated hypertension, severe liver disease (liver
enzymes increase by more than 5 times the upper limit or normal) or severely impaired
renal function (estimated creatinine clearance <30 ml/min), or other that in the
judgement of the investigators pose too great potential for side effects

6. Weight < 45 kg

7. Suicide risk or likely to require psychiatric hospitalization during the course of the
study

8. Requiring ongoing concomitant therapy with a psychotropic drug (other than as needed,
anxiety medications, and pain control medications) and unable or unwilling to comply
with the washout period.
;
Inclusion Criteria:

1. Age > 25 years.

2. Meet DSM-IV criteria for anxiety disorder as indicated by the Structured Clinical
Interview for the DSM (SCID)-IV or have a score of at least 40 on the state- or trait
STAI scale at study inclusion.

3. 40% or more of the participants should have a diagnosis of advanced-stage potentially
fatal illness (autoimmune, neurological, or cancer without central nervous system
(CNS) involvement). Patients should be ambulatory and not terminal and likely to have
a roughly estimated life expectancy of > twelve months.

4. Patients without advanced-stage potentially fatal illness need to meet DSM-IV criteria
for anxiety disorder (elevated STAI score not sufficient for inclusion)

5. Sufficient understanding of the study procedures and risks associated with the study.

6. Participants must be willing to adhere to the study procedures and sign the consent
form.

7. Participants are willing to refrain from taking any psychiatric medications during the
experimental session period. If they are being treated with antidepressants or are
taking anxiolytic medications on a fixed daily regimen such drugs must be discontinued
long enough before the LSD/placebo treatment session to avoid the possibility of a
drug-drug interaction (the interval will be at least 5 times the particular drug's
half-life [typically 3-7 days]).

8. If in ongoing psychotherapy, those recruited into the study may continue to see their
outside therapist, provided they sign a release for the investigators to communicate
directly with their therapist. Participants should not change therapists, increase or
decrease the frequency of therapy or commence any new type of therapy during the study
(not including the follow-up).

9. Participants must also refrain from the use of any psychoactive drugs, with the
exception of the long term pain medication or caffeine or nicotine, within 24 hours of
each LSD/placebo treatment session. They must agree not to use nicotine for at least 2
hours before and 6 hours after each dose of LSD. They must agree to not ingest
alcohol-containing beverages for at least 1 day before each LSD treatment session.
Non-routine medications for treating breakthrough pain taken in the 24 hours before
the LSD treatment session may result in rescheduling the treatment session to another
date, with the decision at the discretion of the investigators after discussion with
the participant.

10. Participants must be willing not to drive a traffic vehicle or to operate machines
within 24 h after LSD/placebo administration.

Exclusion Criteria:

1. Women who are pregnant or nursing, or of child bearing potential and are not
practicing an effective means of birth control (double-barrier method, i.e.
pill/intrauterine device and preservative/diaphragm).

2. Past or present diagnosis of a primary psychotic disorder. Subjects with a first
degree relative with psychotic disorders are also excluded.

3. Past or present bipolar disorder (DSM-IV)

4. Current substance use disorder (within the last 2 months, DSM-V, except nicotine)

5. Somatic disorders including central nervous system (CNS) involvement of the cancer,
severe cardiovascular disease, untreated hypertension, severe liver disease (liver
enzymes increase by more than 5 times the upper limit or normal) or severely impaired
renal function (estimated creatinine clearance <30 ml/min), or other that in the
judgement of the investigators pose too great potential for side effects

6. Weight < 45 kg

7. Suicide risk or likely to require psychiatric hospitalization during the course of the
study

8. Requiring ongoing concomitant therapy with a psychotropic drug (other than as needed,
anxiety medications, and pain control medications) and unable or unwilling to comply
with the washout period.
;
Inclusion Criteria:

1. Age > 25 years.

2. Meet DSM-IV criteria for anxiety disorder as indicated by the Structured Clinical
Interview for the DSM (SCID)-IV or have a score of at least 40 on the state- or trait
STAI scale at study inclusion.

3. 40% or more of the participants should have a diagnosis of advanced-stage potentially
fatal illness (autoimmune, neurological, or cancer without central nervous system
(CNS) involvement). Patients should be ambulatory and not terminal and likely to have
a roughly estimated life expectancy of > twelve months.

4. Patients without advanced-stage potentially fatal illness need to meet DSM-IV criteria
for anxiety disorder (elevated STAI score not sufficient for inclusion)

5. Sufficient understanding of the study procedures and risks associated with the study.

6. Participants must be willing to adhere to the study procedures and sign the consent
form.

7. Participants are willing to refrain from taking any psychiatric medications during the
experimental session period. If they are being treated with antidepressants or are
taking anxiolytic medications on a fixed daily regimen such drugs must be discontinued
long enough before the LSD/placebo treatment session to avoid the possibility of a
drug-drug interaction (the interval will be at least 5 times the particular drug's
half-life [typically 3-7 days]).

8. If in ongoing psychotherapy, those recruited into the study may continue to see their
outside therapist, provided they sign a release for the investigators to communicate
directly with their therapist. Participants should not change therapists, increase or
decrease the frequency of therapy or commence any new type of therapy during the study
(not including the follow-up).

9. Participants must also refrain from the use of any psychoactive drugs, with the
exception of the long term pain medication or caffeine or nicotine, within 24 hours of
each LSD/placebo treatment session. They must agree not to use nicotine for at least 2
hours before and 6 hours after each dose of LSD. They must agree to not ingest
alcohol-containing beverages for at least 1 day before each LSD treatment session.
Non-routine medications for treating breakthrough pain taken in the 24 hours before
the LSD treatment session may result in rescheduling the treatment session to another
date, with the decision at the discretion of the investigators after discussion with
the participant.

10. Participants must be willing not to drive a traffic vehicle or to operate machines
within 24 h after LSD/placebo administration.

Exclusion Criteria:

1. Women who are pregnant or nursing, or of child bearing potential and are not
practicing an effective means of birth control (double-barrier method, i.e.
pill/intrauterine device and preservative/diaphragm).

2. Past or present diagnosis of a primary psychotic disorder. Subjects with a first
degree relative with psychotic disorders are also excluded.

3. Past or present bipolar disorder (DSM-IV)

4. Current substance use disorder (within the last 2 months, DSM-V, except nicotine)

5. Somatic disorders including central nervous system (CNS) involvement of the cancer,
severe cardiovascular disease, untreated hypertension, severe liver disease (liver
enzymes increase by more than 5 times the upper limit or normal) or severely impaired
renal function (estimated creatinine clearance <30 ml/min), or other that in the
judgement of the investigators pose too great potential for side effects

6. Weight < 45 kg

7. Suicide risk or likely to require psychiatric hospitalization during the course of the
study

8. Requiring ongoing concomitant therapy with a psychotropic drug (other than as needed,
anxiety medications, and pain control medications) and unable or unwilling to comply
with the washout period.
;
Inclusion Criteria:

1. Age > 25 years.

2. Meet DSM-IV criteria for anxiety disorder as indicated by the Structured Clinical
Interview for the DSM (SCID)-IV or have a score of at least 40 on the state- or trait
STAI scale at study inclusion.

3. 40% or more of the participants should have a diagnosis of advanced-stage potentially
fatal illness (autoimmune, neurological, or cancer without central nervous system
(CNS) involvement). Patients should be ambulatory and not terminal and likely to have
a roughly estimated life expectancy of > twelve months.

4. Patients without advanced-stage potentially fatal illness need to meet DSM-IV criteria
for anxiety disorder (elevated STAI score not sufficient for inclusion)

5. Sufficient understanding of the study procedures and risks associated with the study.

6. Participants must be willing to adhere to the study procedures and sign the consent
form.

7. Participants are willing to refrain from taking any psychiatric medications during the
experimental session period. If they are being treated with antidepressants or are
taking anxiolytic medications on a fixed daily regimen such drugs must be discontinued
long enough before the LSD/placebo treatment session to avoid the possibility of a
drug-drug interaction (the interval will be at least 5 times the particular drug's
half-life [typically 3-7 days]).

8. If in ongoing psychotherapy, those recruited into the study may continue to see their
outside therapist, provided they sign a release for the investigators to communicate
directly with their therapist. Participants should not change therapists, increase or
decrease the frequency of therapy or commence any new type of therapy during the study
(not including the follow-up).

9. Participants must also refrain from the use of any psychoactive drugs, with the
exception of the long term pain medication or caffeine or nicotine, within 24 hours of
each LSD/placebo treatment session. They must agree not to use nicotine for at least 2
hours before and 6 hours after each dose of LSD. They must agree to not ingest
alcohol-containing beverages for at least 1 day before each LSD treatment session.
Non-routine medications for treating breakthrough pain taken in the 24 hours before
the LSD treatment session may result in rescheduling the treatment session to another
date, with the decision at the discretion of the investigators after discussion with
the participant.

10. Participants must be willing not to drive a traffic vehicle or to operate machines
within 24 h after LSD/placebo administration.

Exclusion Criteria:

1. Women who are pregnant or nursing, or of child bearing potential and are not
practicing an effective means of birth control (double-barrier method, i.e.
pill/intrauterine device and preservative/diaphragm).

2. Past or present diagnosis of a primary psychotic disorder. Subjects with a first
degree relative with psychotic disorders are also excluded.

3. Past or present bipolar disorder (DSM-IV)

4. Current substance use disorder (within the last 2 months, DSM-V, except nicotine)

5. Somatic disorders including central nervous system (CNS) involvement of the cancer,
severe cardiovascular disease, untreated hypertension, severe liver disease (liver
enzymes increase by more than 5 times the upper limit or normal) or severely impaired
renal function (estimated creatinine clearance <30 ml/min), or other that in the
judgement of the investigators pose too great potential for side effects

6. Weight < 45 kg

7. Suicide risk or likely to require psychiatric hospitalization during the course of the
study

8. Requiring ongoing concomitant therapy with a psychotropic drug (other than as needed,
anxiety medications, and pain control medications) and unable or unwilling to comply
with the washout period.

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT03153579

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03153579

Weitere Informationen zur Studie

Registrationsdatum der Studie

09.05.2017

Einschluss der ersten teilnehmenden Person

31.05.2017

Rekrutierungsstatus

Recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

LSD Treatment in Persons Suffering From Anxiety Symptoms in Severe Somatic Diseases or in Psychiatric Anxiety Disorders: a Randomized, Double-blind, Placebo-controlled Phase II Study

Studientyp (Datenquelle: WHO)

Interventional

Design der Studie (Datenquelle: WHO)

Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).

Phase (Datenquelle: WHO)

Phase 2

Primäre Endpunkte (Datenquelle: WHO)

Reduction in anxiety assessed by questionnaires;Reduction in anxiety assessed by questionnaires;Reduction in anxiety assessed by questionnaires

Sekundäre Endpunkte (Datenquelle: WHO)

Reduction in Depression assessed by questionnaires;Reduction in anxiety assessed by questionnaires;Reduction of psychopathological symptoms assessed by questionnaires;Sustained Response assessed by questionnaires

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Studiendurchführungsorte

Durchführungsorte in der Schweiz (Datenquelle: BASEC)

Basel, Solothurn

Durchführungsländer (Datenquelle: WHO)

Switzerland

Kontakt für weitere Auskünfte zur Studie

Angaben zur Kontaktperson in der Schweiz (Datenquelle: BASEC)

Prof. Dr.med. Matthias Liechti
+41613286868
matthias.liechti@usb.ch

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Peter Gasser, MD;Matthias E Liechti, MD, MAS;Peter Gasser, MD;Matthias E Liechti, MD, MAS;Peter Gasser, MD;Matthias E Liechti, MD, MAS;Peter Gasser, MD;Matthias E Liechti, MD, MAS;Peter Gasser, MD;Matthias E Liechti, MD, MAS
Private Practice;;Private Practice;;Private Practice;;Private Practice;;Private Practice;
;+ 41 61 265 2525;;+ 41 61 265 2525;;+ 41 61 265 2525;;+ 41 61 265 2525;;+ 41 61 265 2525
;matthias.liechti@usb.ch;;matthias.liechti@usb.ch;;matthias.liechti@usb.ch;;matthias.liechti@usb.ch;;matthias.liechti@usb.ch

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Peter Gasser, MD;Matthias E Liechti, MD, MAS;Peter Gasser, MD;Matthias E Liechti, MD, MAS;Peter Gasser, MD;Matthias E Liechti, MD, MAS;Peter Gasser, MD;Matthias E Liechti, MD, MAS;Peter Gasser, MD;Matthias E Liechti, MD, MAS
Private Practice;;Private Practice;;Private Practice;;Private Practice;;Private Practice;
;+ 41 61 265 2525;;+ 41 61 265 2525;;+ 41 61 265 2525;;+ 41 61 265 2525;;+ 41 61 265 2525
;matthias.liechti@usb.ch;;matthias.liechti@usb.ch;;matthias.liechti@usb.ch;;matthias.liechti@usb.ch;;matthias.liechti@usb.ch

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

University Hospital, Basel, Switzerland

Weitere Studienidentifikationsnummern

BASEC ID (Datenquelle: BASEC)

2016-00992

Secondary ID (Datenquelle: WHO)

BASEC 2016-00992