Major Depression (ICD-10
Conditions
Interventions
Trade Name: Cycloserine
Product Name: Cycloserin-Kapseln
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: CYCLOSERINE
CAS Number: 68-41-7
Concentration unit: mg milligram(s)
Concentration type
Sponsors
University Medical Center Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
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 ;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 ;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
Exclusion criteria
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 ;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 ;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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the hypothesis that the efficacy of Interpersonal Psychotherapy (IPT) can be enhanced by co-administration of the NMDA-receptor agonist D-cycloserine in patients with major depressive disorder.;Secondary Objective: "Not applicable";Primary end point(s): Change in depressive symptomatology as assessed by HAMD at week 8 compared to baseline.;Timepoint(s) of evaluation of this end point: Baseline (beginning of treatment) vs. after treatment (week 8);Main Objective: Investigate the hypothesis that the efficacy of Interpersonal Psychotherapy (IPT) can be enhanced by co-administration of the NMDA-receptor agonist D-cycloserine in patients with major depressive disorder.;Secondary Objective: "Not applicable";Primary end point(s): Change in depressive symptomatology as assessed by HAMD at week 8 compared to baseline.;Timepoint(s) of evaluation of this end point: Baseline (beginning of treatment) vs. after treatment (week 8);Main Objective: Investigate the hypothesis that the efficacy of Interpersonal Psychotherapy (IPT) can be enhanced by co-administration of the NMDA-receptor agonist D-cycloserine in patients with major depressive disorder.;Secondary Objective: "Not applicable";Primary end point(s): Change in depressive symptomatology as assessed by HAMD at week 8 compared to baseline.;Timepoint(s) of evaluation of this end point: Baseline (beginning of treatment) vs. after treatment (week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rates of response (50% reduction on the HAMD) and remission (<10 on the HAMD) at week 8, self-reported outcomes of depressive symptoms as assessed by the Beck Depression Inventory (BDI). Change in inducability of LTP-like synaptic plasticity (changes of size of TMS-evoked MEP-amplitudes before vs. after PAS) at week 1 (first DCS-capsule) and at week 8 compared to baseline. Changes in declarative memory (word-pair task),working memory (digit span) and attentional performance (TAP-Alertness ).;Timepoint(s) of evaluation of this end point: Baseline (beginning of treatment) vs. after treatment (week 8);Secondary end point(s): Rates of response (50% reduction on the HAMD) and remission (<10 on the HAMD) at week 8, self-reported outcomes of depressive symptoms as assessed by the Beck Depression Inventory (BDI). Change in inducability of LTP-like synaptic plasticity (changes of size of TMS-evoked MEP-amplitudes before vs. after PAS) at week 1 (first DCS-capsule) and at week 8 compared to baseline. Changes in declarative memory (word-pair task),working memory (digit span) and attentional performance (TAP-Alertness ).;Timepoint(s) of evaluation of this end point: Baseline (beginning of treatment) vs. after treatment (week 8);Secondary end point(s): Rates of response (50% reduction on the HAMD) and remission (<10 on the HAMD) at week 8, self-reported outcomes of depressive symptoms as assessed by the Beck Depression Inventory (BDI). Change in inducability of LTP-like synaptic plasticity (changes of size of TMS-evoked MEP-amplitudes before vs. after PAS) at week 1 (first DCS-capsule) and at week 8 compared to baseline. Changes in declarative memory (word-pair task),working memory (digit span) and attentional performance (TAP-Alertness ).;Timepoint(s) of evaluation of this end point: Baseline (beginning of treatment) vs. after treatment (week 8) | — |
Countries
Germany
Contacts
Public ContactUniversity Medical Center Freiburg;University Medical Center Freiburg;University Medical Center Freiburg ;;
University Medical Center Freiburg;University Medical Center Freiburg;University Medical Center Freiburg
Outcome results
None listed