Effects of Passion Flower Extract, as an Add-on Treatment to Sertraline, on Reaction Time in Patients with Generalized Anxiety Disorder: a Double-blind Placebo-Controlled Study

The Generalized Anxiety Disorder (GAD) is defined as the basic anxiety disorder, which may reflect ?the fundamental process of all emotional disorders and significant degree of functional ?impairment (1). GAD is hyper-reactivity and a fear of negative emotional shifts and ?unmanageable worry about preventing these perceptive contrasts (2). The symptoms are difficult ?to control and last for more than six months. GAD is associated with three or more of diagnostic ?items from DSM-IV (Diagnostic and Statistical manual of Mental illnesses-4th edition) including: ?Feeling keyed up or on edge, easily getting fatigue, mind going blank, agitation, somatic tension ?and sleep disturbances. Treatment choices include psychological therapies such as cognitive ?behavioral therapy (CBT) as the main nonpharmacological therapy (3), acceptance and ?commitment therapy (4), intolerance of uncertainty therapy and motivational interviewing (5) as ?well as pharmacotherapy including Selective Serotonin Reuptake Inhibitors (SSRIs) (6), Benzodiazepines (7), Pregabalin (8) and ?Gabapentin (9), Tricyclic Antidepressants (TCAs), Buspirone and Hydroxyzine (6). Reaction Time (RT) is defined as the time ?elapsed between offering stimuli and the indication of comprehension by the subject (10). RT is ?claimed to be the main dependent variable for analyzing perceptive models (11).Response procedure is directly based on circumstances (12). Many factors may be responsible for ?reaction time fluctuations, specially a great number of drugs and substances e.g., Caffeine (13), ?alcohol (14), psychostimulants (15), sedative-hypnotic and antiepileptic drugs (16, 17) and many ?of cognitive side effects, which are raised by psychiatric pharmacotherapies (18, 19).Passion flower symbolizes the passion of Jesus in Christian theology because of its unique ?structure (20). ?Traditionally its extract has been used as an herbal remedy for nervous anxiety (21) and ?insomnia, tenderness, restlessness, irritability (22) and hysteria (23). Passion flower has been ?reported to affect GAD (24). Most of these effects are believed to be related to benzoflavone, ?which is the active constituent of the plant extract (25). We aimed to investigate the effects of ?passion flower extract on perceptual processing toward threats via reaction time test since its ?advantage on mental function did not receive specific reflections in previous studies.??Materials and MethodResearch ParticipantsThirty outpatients entered this randomized doubleblind placebo-controlled study (Ethical ?approval number 7408 - by Ethics Committee at Islamic Azad University of Pharmaceutical ?Sciences). The participants were included in the study from Roozbeh and Baharloo hospitals and ?private psychiatric offices during 2010- 2012. Patients were diagnosed with Generalized Anxiety ?Disorder (GAD) based on DSMIV criteria and clinical interviews. Their family history was ?considered as well. They were tested using Hamilton Anxiety Rating Scale Form A (HARS). ?Hamilton Rating Scale for Depression (HRSD) was utilized to determine the patients' comorbid ?depression. The Hamilton Scales were standardized for Iranian patients.Patients between 18 to 24 years of age were included. In addition, sertraline consumption was ?considered the best treatment for their current disease per decision of the psychiatrist. All patients ?were initiated on Sertraline. The exclusion criteria were as follows: Having difficulty including ?allergic reactions to sertraline or active ingredients of passion flower, renal or hepatic impairment, ?age under 18, pregnancy and lactation, consuming Warfarin, Hexobarbital, Pantobarbital, ?Levothyroxine or other thyroid medications, using alcohol or hallucinogens and history of ?tachycardia. The patients with a history of kidney or liver dysfunction were excluded. An ?informed consent was obtained from the patients prior to the initiation of the examination. ?MedicationThe first-line treatment for GAD patients was 50 mg Sertraline tablet for both groups. …