euroenhancement of Interpersonal Psychotherapy in Major Depressio

Phase 1

• Conditions: Major Depression (ICD-10; F32.2/F33.2); Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-001541-24-DE
• Lead Sponsor: niversity Medical Center Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-04
• Last Update Posted: 13 February 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Major depressive disorder (ICD-10: F32.2 and F33.2)
Inpatients at the Department of Psychiatry and Psychotherapy, Freiburg
Score of =15 on the 21-item Hamilton Rating Scale for Depression (HAMD)
20-60 years of age
Ability to provide informed consent
Normal or corrected-to-normal vision
Absence of any exclusion criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
;
Major depressive disorder (ICD-10: F32.2 and F33.2)
Inpatients at the Department of Psychiatry and Psychotherapy, Freiburg
Score of =15 on the 21-item Hamilton Rating Scale for Depression (HAMD)
20-60 years of age
Ability to provide informed consent
Normal or corrected-to-normal vision
Absence of any exclusion criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
;
Major depressive disorder (ICD-10: F32.2 and F33.2)
Inpatients at the Department of Psychiatry and Psychotherapy, Freiburg
Score of =15 on the 21-item Hamilton Rating Scale for Depression (HAMD)
20-60 years of age
Ability to provide informed consent
Normal or corrected-to-normal vision
Absence of any exclusion criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hypersensitivity to D-cycloserine
Neurological disorders including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome
Metallic implants
Present pregnancy
DSM-V axis I disorder (lifetime) apart from major depression, such as schizophrenia, schizoaffective disorder, any non-bipolar psychotic disorder, bipolar disorders, primary anxiety or obsessive compulsive disorder, mental retardation, signs of impaired cognitive functioning
Acute suicidality
Psychotic features of MDD
Lifetime history for drug/alcohol dependence, or drug/alcohol abuse within the past year
Medication with any anxiolytic or antipsychotic drug, except antidepressants for patients
Medical conditions including severe cardiac, liver, kidney, endocrine (e.g., diabetes), hematologic disorders (e.g., porphyria or any bleeding abnormalities), other impairing or unstable medical condition or impending surgery
Inability to read or understand the study forms and agree to informed consent.
Left-handedness

;
Hypersensitivity to D-cycloserine
Neurological disorders including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome
Metallic implants
Present pregnancy
DSM-V axis I disorder (lifetime) apart from major depression, such as schizophrenia, schizoaffective disorder, any non-bipolar psychotic disorder, bipolar disorders, primary anxiety or obsessive compulsive disorder, mental retardation, signs of impaired cognitive functioning
Acute suicidality
Psychotic features of MDD
Lifetime history for drug/alcohol dependence, or drug/alcohol abuse within the past year
Medication with any anxiolytic or antipsychotic drug, except antidepressants for patients
Medical conditions including severe cardiac, liver, kidney, endocrine (e.g., diabetes), hematologic disorders (e.g., porphyria or any bleeding abnormalities), other impairing or unstable medical condition or impending surgery
Inability to read or understand the study forms and agree to informed consent.
Left-handedness

;
Hypersensitivity to D-cycloserine
Neurological disorders including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome
Metallic implants
Present pregnancy
DSM-V axis I disorder (lifetime) apart from major depression, such as schizophrenia, schizoaffective disorder, any non-bipolar psychotic disorder, bipolar disorders, primary anxiety or obsessive compulsive disorder, mental retardation, signs of impaired cognitive functioning
Acute suicidality
Psychotic features of MDD
Lifetime history for drug/alcohol dependence, or drug/alcohol abuse within the past year
Medication with any anxiolytic or antipsychotic drug, except antidepressants for patients
Medical conditions including severe cardiac, liver, kidney, endocrine (e.g., diabetes), hematologic disorders (e.g., porphyria or any bleeding abnormalities), other impairing or unstable medical condition or impending surgery
Inability to read or understand the study forms and agree to informed consent.
Left-handedness

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified