Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Proof-of-Concept, Double-blind, Randomized, Placebo-controlled Study of Ganaxolone in Posttraumatic Stress Disorder
Brief Summary: This Phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, 15-week investigation of ganaxolone versus placebo for the treatment of Posttraumatic Stress Disorder (PTSD). Up to 120 participants will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks. After 6 weeks of randomized treatment all participants will continue for 6 weeks on ganaxolone. The aim of the study is to assess the efficacy of ganaxolone compared to placebo for the treatment of PTSD symptoms after 6 weeks of treatment using the Clinician-Administered PTSD Rating Scale (CAPS). The second aim of the study is to evaluate the safety and tolerability of ganaxolone in the PTSD population.


Options:
A: Arm Label: psychotherapy; Type: EXPERIMENTAL; Interventions: Behavioral: trauma-focused cognitive behavioural therapy | Arm Label: Drug; Type: EXPERIMENTAL; Interventions: Drug: Sertraline | Arm Label: Waiting list; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Combination; Type: EXPERIMENTAL; Interventions: Drug: Sertraline, Behavioral: trauma-focused cognitive behavioural therapy | Intervention Type: DRUG; Name: Sertraline; Assigned to Arm(s): Combination, Drug | Intervention Type: BEHAVIORAL; Name: trauma-focused cognitive behavioural therapy; Assigned to Arm(s): Combination, psychotherapy
B: Arm Label: Ganaxolone; Type: EXPERIMENTAL; Interventions: Drug: Ganaxolone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Ganaxolone; Assigned to Arm(s): Ganaxolone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: GR205171; Type: EXPERIMENTAL; Interventions: Drug: NK1 Antagoist (GR205171), Procedure: Psychophysiology (Trauma Script), Procedure: Psychophysiology (Verbal Threat), Procedure: Psychophysiology (Fear Conditioning), Procedure: Psychophysiology (Affective Modulation), Procedure: Psychophysiology (Heart rate variability), Procedure: Lumbar Puncture, Procedure: 24-hour plasma sampling, Procedure: MRI | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Psychophysiology (Trauma Script), Procedure: Psychophysiology (Verbal Threat), Procedure: Psychophysiology (Fear Conditioning), Procedure: Psychophysiology (Affective Modulation), Procedure: Psychophysiology (Heart rate variability), Procedure: Lumbar Puncture, Procedure: 24-hour plasma sampling, Procedure: MRI | Intervention Type: DRUG; Name: NK1 Antagoist (GR205171); Assigned to Arm(s): GR205171 | Intervention Type: PROCEDURE; Name: Psychophysiology (Trauma Script); Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: Psychophysiology (Verbal Threat); Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: Psychophysiology (Fear Conditioning); Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: Psychophysiology (Affective Modulation); Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: Psychophysiology (Heart rate variability); Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: Lumbar Puncture; Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: 24-hour plasma sampling; Assigned to Arm(s): GR205171, placebo | Intervention Type: PROCEDURE; Name: MRI; Assigned to Arm(s): GR205171, placebo
D: Arm Label: Arm 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mirtazapine | Arm Label: Arm 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Mirtazapine; Assigned to Arm(s): Arm 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Arm 2

Answer: B